Upcoming and open funding calls

HORIZON-EURATOM-2023-NRT-01-10

Harnessing innovation in nuclear science, technology and radiation protection

Indicative budget: € 7 million
Opening: 04 April 2023
Deadline(s): 08 November 2013, 17:00:00 Brussels time

Keywords: radiation protection, emergency preparedness, nuclear energy

Expected Outcome

Project results are expected to contribute to some of the following expected outcomes:

• Bring a breakthrough innovation in radiation protection and emergency preparedness to improve protection against ionising radiation, bringing benefits to society using crosscutting technologies like digitalisation, modelling or simulation, and artificial
  intelligence where appropriate.
• Address safety aspects of alternative applications of nuclear energy (e.g. hydrogen production, process heat for energy-intensive industries, district heating and desalinisation), allowing some Member States to contribute to the energy transition according to and respecting the EU technology neutrality principle and thus increase Member State and EU security of supply.
• Develop new nuclear techniques or optimise existing ones in the medical field, addressing in particular safety and radiation protection aspects.
• Support the development of European production of stable isotopes used in novel nuclear medicine therapies.
• Bring innovation in communication about nuclear applications and their risks to ensure informed decisions by stakeholders, civil society and decision-makers.

Scope

This action aims to bring innovation, including via cross-fertilisation with other scientific and technical sectors, to radiation protection. This complements the PIANOFORTE European partnership in medical applications and emergency preparedness, alternative applications of nuclear energy, and risk communication with civil society and decision-makers.

In terms of radiation protection and emergency preparedness, the PIANOFORTE partnership will be the main driving force for research for the coming 5 years, consolidating an EU-wide research and innovation community. The purpose of this action is to complement the PIANOFORTE partnership by fostering frontier research and testing novel ideas that can bring about a breakthrough innovation in the field. The proposals should complement, without duplicating, the research challenges addressed in the PIANOFORTE research roadmap.

In the context of the energy transition and complementing Horizon Europe’s objectives, nuclear energy and innovative nuclear technology applications can provide some Member States with solutions to support climate change mitigation. Nuclear technologies could provide solutions that enable energy-intensive industries to develop and reduce their environmental footprint while remaining competitive. Nuclear has the potential to supply heat to homes, businesses and industrial processes, and produce hydrogen and synthetic fuels or non-electric commodities such as purified water or fertilisers. Some non-electric applications for nuclear energy have been demonstrated and implemented by industry, but their full potential still needs to be demonstrated. The Euratom-funded action should address the safety challenges related to developing and implementing non-electric applications for nuclear energy.

Concerning human health, there are many technologies in various fields of medical applications of ionising radiation. These include targeted radionuclide therapy, targeted therapies based on ion or proton therapy, new technologies for interventional imaging procedures and molecular imaging approaches, and the development of vaccines using irradiation techniques. The rapidly developing medical radiation technologies are becoming more complex and increasingly rely on automation, computerised decision support and AI-based systems. The Euratom-funded action should address the development of new quality assured nuclear techniques or optimisation of existing ones in the medical field. This includes data processing methodologies using artificial intelligence, optimisation of the medical use of ionising radiation and corresponding optimisation of radiation protection.

Each year, patients in Europe benefit from nuclear medicine in diagnosing and treating illnesses such as cancer, cardiovascular or neurological disorders. The EU supply of novel radiopharmaceuticals for cancer therapy is at risk due to the growing uncertainties over imports of enriched stable isotopes from Russia. Ensuring European know-how and the EU’s strategic capabilities in this field is essential for the decades to come.

When communicating about nuclear applications and their risks, proposals are expected to bring about and test novel ideas for risk communication to ensure informed decisions by stakeholders, civil society and decision-makers. Back to top

HORIZON-HLTH-2024-STAYHLTH-01-05-two-stage

Personalised prevention of noncommunicable diseases – addressing areas of unmet needs using multiple data sources

Indicative budget: € 50 million
Opening: 30 March 2023
Deadline(s): 19 September 2023 (first stage) 11 April 2024 (second stage)

Keywords: personalised prevention; population stratification; resource and data integration; non-communicable diseases 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several impacts of destination 1 “Staying healthy in a rapidly changing society.” To that end, proposals under this topic should aim at delivering results that are directed at, tailored towards and contributing to several of the following expected outcomes:

• Citizens have access to and use effective personalised prevention schemes and health counselling (including through digital means) that take into account their individual characteristics and situation. Individuals can be assigned to particular groups based on their characteristics, and receive advice adequate to that group. Stratification of a population into groups showing similar traits allows for effective personalised disease prevention.
• Health professionals use effective, tried and tested tools to facilitate their work when advising both patients and healthy individuals. Public health programme owners gain insight into the specificities and characteristics of disease clusters within the population through stratification. This can then be used to facilitate the identification of population groups with elevated risk of developing certain diseases and improve the programmes, update them and design effective strategies for optimal solutions and interventions.
• National and regional programmes make better use of funds, data infrastructure and personnel in health promotion and disease prevention, primary and secondary healthcare. They can consider the use of new or improved ambitious policy and intervention options, with expected high population-wide impact, for effective health promotion and disease prevention.
• Companies generate opportunities for new product and service developments to cater to the needs of the healthcare service and individuals.

Scope

Non-communicable diseases (NCDs) are responsible for the majority of the disease burden in Europe and are the leading cause of avoidable premature death. The human and financial cost of NCDs is high and expected to grow. Reducing the burden of NCDs requires a holistic approach and tackling health inequalities across the board. Preventing NCDs from developing in the first place will be at the core of successful public health programmes in the future. Personalised approaches and the development of targeted interventions have led to an impressive progress in several fields of medicine and have been included in many treatments. However, the use of stratification and individualisation in guiding prevention strategies is still not widely in use even though examples of its potential are accumulating. Identifying people at risk of developing a particular disease before the disease starts to manifest itself with symptoms greatly improves treatment options. It is estimated that about two thirds of all NCDs are preventable, many affecting people who are unaware of their disease risks or do not have access to information pertaining to the management of the condition. Personalised prevention is the assessment of health risks for individuals based on their specific background traits to recommend tailored prevention. This can include any evidence-based method. Personalised prevention strategies complement general public health prevention programmes without replacing them, optimising the benefit of both approaches. Personalised prevention is ideally suited to the use of large data sets, computational and omics approaches, with design and use of algorithms, integrating in-depth biological and medical information, machine learning, artificial intelligence (AI) and ‘virtual twin’ technology, taking into account explainable and transparent AI. . The funded projects will work towards reducing the burden of NCDs in line with the ‘Healthier Together’ – EU Non-Communicable Diseases Initiative. This does not limit the scope of projects under this topic to particular diseases as any disease area of interest, comorbidities and health determinants can be addressed. Accordingly, the proposed research is expected to deliver on all of the following points:

• Enable the understanding of areas of unmet need in NCDs prevention, possibly also addressing disease mechanism, management of disease progression and relapse. Providing new approaches for prevention, focussing on the digitally supported personalised dimension, that can be adopted and scaled up.
• Devise new or improved ambitious policy and intervention options, with expected high population-wide impact on the target groups in question. To be proposed and made available for effective health promotion and disease prevention including targeted communication strategies to successfully reach out to the risk groups.
• Design an integrated, holistic approach that includes several of the following aspects: genetic predisposition to NCDs, meta-genomics, epigenomics, the microbiome, metabolomics, sleep disorders, large cohorts, molecular profiling in longitudinal health screening, impact of lack of physical activity, novel predictive biomarker candidates, diets and nutrition, eating habits for designing customised dietary patterns (geographical variation), and the influence of choice environment on personal choices.
• Study the ethical, legal and social aspects as well as health economics of the personalised prevention tools and programmes being developed. Consider optimal health counselling and communication to the patients/citizens. Address legal aspects of balancing the right not to know and the obligation of helping people in danger.

Furthermore, the proposed research is expected to deliver on several of the following points:

• Develop and validate effective strategies to prevent NCDs and optimise health and wellbeing of citizens (including the most vulnerable). Propose the strategies to policymakers along with mechanisms to monitor their progress. The strategies need to be aligned with relevant national and European health laws and policies.
• Provide scientific evidence on interactions between the genetic predisposition to multifactorial diseases and environmental factors or environmental triggers. Propose scientifically supported personalised prevention strategies that ensure how to modify the environmental drivers of behavioural risk factors.
• Develop new computational tools combining and analysing comprehensive data with different dimensions to identify risk factors and modifiers. Creating procedures and algorithms to combine information from different sources (with standardised common data models) to generate risk scores for several diseases and provide health promotion recommendations for the individual as advised by healthcare professionals. Furthermore, develop advanced computational modelling techniques for predicting disease risk and predisposition (addressed together in an integrative approach) and identifying the optimal solution/intervention for different target groups and individuals.
• Develop tools and techniques to increase the efficiency and cost- effectiveness of on the one hand interventions, adjusting their scope, characteristics and resources, and on the other hand healthcare infrastructure and how it promotes and delivers health promotion, disease prevention, and care effectively to the different population groups.
• Design tools to collect various data to advance health promotion and disease prevention and strategies for providing omics essays for the general patient with a focus on costeffectiveness and flexibility.
• Determine how to optimise the benefits of physical activity, smart monitoring of physical activity and sedentary behaviour with measurable data, addressing barriers to uptake and implementation of healthy lifestyles in daily life, understanding what promotion methods work and why, behavioural science to understand healthier choice environments. Balancing the ecosystem associated with the economic, social, and health consequences of NCDs. Affordability related consideration should be taken into account to ensure accessibility of new tools and techniques.
• Conduct data mining of real-world data and develop quantifiable and distinguishable indicators from wearables data, taking into account ‘light-weight’ AI means to ensure patient privacy and short reaction times.Demonstrate with a practical prototype on a given health challenge: from multimodal data collection to identification of an effective prevention strategy to be tested and validated for one or several NCDs.

Where relevant, the projects should contribute to and create synergies with ongoing national, European and international initiatives such as the European Partnership for Personalised Medicine, the ‘Healthier Together’ – EU Non-Communicable Diseases Initiative, Europe’s Beating Cancer Plan and the Mission on Cancer, WHO’s 9 targets for NCDs, the EMA ‘Darwin’ network, etc. This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities. Where relevant, activities should build on and expand results of past and ongoing research projects. Selected projects under this topic are expected to participate in joint activities as appropriate, possibly including also related projects from other call topics. This can take the form of project clustering, workshops, joint dissemination activities etc. Applicants should plan a necessary budget to cover this collaboration. Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part. Back to top

HORIZON-HLTH-2023-ENVHLTH-02-03

Health impacts of endocrine-disrupting chemicals: bridging science-policy gaps by addressing persistent scientific uncertainties

Indicative budget: € 40 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: EU environmental frameworks; occupational safety; risk assessment; endocrine disruptors; public health guidelines

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 2 ‘Living and working in a health-promoting environment.’ To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to all of the following expected outcomes:

• Public authorities including EU risk assessment bodies and regulators are supported with scientific evidence to implement the comprehensive European Union Framework on Endocrine Disruptors, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, EU legislation on plant protection products and EU occupational safety and health legislation;
• Public authorities improve their risk assessment, management and communication through access to FAIR data and more robust evidence on the causal links between exposure to endocrine disruptors and health outcomes for which insufficient data exist;
• Research community has better data on the role of endocrine disruptors and other cofactors (e.g., lifestyle, behavioural, socio-economic) to enable a better understanding of their individual or combined health impacts;
• Public authorities and the scientific community take advantage of latest methodologies for advancing the understanding of health impact of exposures;
• Public authorities, employers and citizens rely on practical evidence-informed guidelines for exposure prevention and reduction;
• Citizens are engaged and informed about the health impact of exposures to endocrine disruptors and risk-preventing behaviours are promoted.

Scope

The function and regulation of the endocrine system in humans and other species is of high biological complexity. Endocrine disrupting chemicals (EDCs or endocrine disruptors) are chemical substances that alter the functioning of the endocrine system and negatively affect the health of humans and animals. They may either be of synthetic or natural origin.

EDCs are of increasing importance in chemical regulations in the European Union. According to the Comprehensive European Union Framework on Endocrine Disruptors, adopted in 2018, the EU strategic approach on endocrine disruptors for the years to come should be based on the application of the precautionary principle. This approach would aim at, inter alia, minimising overall exposure of humans and the environment to endocrine disruptors, paying particular attention to exposures during important periods of development of an organism, such as foetal development and puberty, possibly integrating a life course approach, as well as accelerating the development of a thorough research basis for effective and forward-looking decision-making. This includes research for the further management of chemicals (including multi-constituent chemicals as well as chemical mixtures), the understanding of the mechanistic effects of endocrine disruptors and their dose-response relationships (including at the molecular and cellular level through the use of new approach methodologies, such as ‘multiomics’, cheminformatics, in vitro 2D and 3D models, in vivo models and computational approaches), and the collection, sharing, harmonisation and combination of robust data sources.

Closing existing knowledge gaps in the understanding of EDC effects will support more effective and evidence-based regulations at the European level.

Bringing together, inter alia, (molecular) epidemiologists, exposure scientists, toxicologists, endocrinologists, health care practitioners and risk assessors, research actions under this topic should focus on the understanding of the impact of exposures at critical life stages as regards development of diseases later in life, focusing on the several health endpoints for which there is currently less information available. Advantage should be taken of existing biobanks and disease registries and/or cohorts, with carefully planned measurement strategies and clearly worked-out hypotheses. The nature of the dose-response relationships and whether effects are threshold-dependent should be addressed in the study designs. Similarities between endocrine systems and certain health outcomes across species should be exploited to improve understanding of functioning of the endocrine system. Finally, research should attempt at identifying predictive biomarkers (e.g. from liquid biopsies such as saliva, urine, blood) that would allow the tracing of endocrine disrupter-mediated health effects in a shorter period of time than normally would be required for epidemiological studies.

Research actions under this topic should provide forward-looking mechanistic information on potential hazards and health risks of exposures to EDCs, through innovative molecular epidemiological, multifactorial models and systems biology approaches, exploiting the use of state of the art non-animal methodologies when relevant, and should include several of the following activities:

• Studying the impact of EDCs on target organs and in multi-organ models, and physiological barriers, such as the placenta, the blood-brain barrier, the blood-saliva barrier, intestinal, pulmonary and immune cells as well as their interaction with
  microbiota. This should include the provision of a thorough understanding of dose-response relationships;
• Elucidating health endpoints for which insufficient data exist, such as disturbances in the development and functioning of the nervous and cardiovascular systems, the immune system, bone development and disease, obesity, diabetes, hormone-dependent cancers and fertility (e.g. minipuberty, prepuberty and puberty);
• Providing better biological and imaging biomarkers to predict EDC-mediated health outcomes, including the quantitative probabilities of having an adverse effect based on such biomarkers;
• Gaining better insights into the developmental origins of health and disease, especially for those where less data are available. Assessing the occurrence and relevance of multiand transgenerationally inherited effects, including molecular and epigenetic
  mechanisms that drive multigenerational effects;
• Gaining better insights into the most sensitive windows of susceptibility, during which exposure are of particular importance for health effects;
• Better understanding of the effects of chemicals and chemical mixtures on the underlying mechanistic crosstalk between endocrine axes, endocrine pathways and other key biological systems, including immune, neurological and metabolic functions;
• Improving the understanding of chemical mixture effects, including with other toxins and at low doses. The role of the microbiome in the activation or detoxification of these chemicals should be explored where relevant.
• Investigating biological effects of realistic mixtures to get a more detailed understanding of the endocrine effectome, taking advantage of computational toxicology and development of up-to-date models;
• Performing comparative analysis between species, assessing similarities to human endocrine system and health outcomes and exploiting non-mammalian species as test organisms, e.g., non-mammalian vertebrates and invertebrates to predict effects or raise
  concern about potential effects in humans or vice versa;
• Exploiting systems biology approaches in order to understand how exposure to an EDC results in an altered phenotype, a process that implies complex interactions across multiple levels of biological organisation.

Aspects such as gender, regional variations, socioeconomics and culture should be considered, where appropriate. Proposals should ensure that chemical monitoring data are shared in IPCHEM through involvement with the European Commission’s Joint Research Centre (JRC). Proposals should also consider involving JRC with respect to the value it could bring in providing an effective interface between the research activities and regulatory aspects and/or to translating the research results into validated test methods and strategies fit for regulatory purpose. In that respect, the JRC will collaborate with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.

Applicants should be acquainted with planned activities under the European partnership for the assessment of risks from chemicals PARC. PARC will be informed about successful proposals. Successful proposals will be invited to establish synergies with PARC and take advantage of the partnership as a facilitator for open data and methodology sharing with risk assessors and their scientific networks.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the
societal impact of the related research activities.

In order to optimise synergies and increase the impact of the projects, all projects selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities. Without the prerequisite to detail concrete joint activities,
proposals should allocate a sufficient budget for the attendance to regular joint meetings and to cover the costs of any other potential common networking and joint activities.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2023-DISEASE-03-01

Novel approaches for palliative and end-of-life care for non-cancer patients

Indicative budget: € 50 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: palliative care; patient end of life; quality of care; decision-making; clinical guidelines; healthcare sustainability

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden.” To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• Reduced health-related suffering and improved well-being and quality of life of patients in need of palliative and end-of-life care and their professional and family caregivers.
• Patients have early and better access to palliative or end-of-life care services of higher quality and (cost) effectiveness.
• Patients and their professional and family caregivers are able to engage meaningfully with the improved evidence-based and information-driven palliative care joint decision-making process.
• Health care providers and health policymakers have access to and use the improved clinical guidelines and policy with respect to pain and/or other symptoms management, psychological and/or spiritual support, and palliative or end-of-life care for patients.
• Reduced societal, healthcare and economic burden associated with increasing demands of palliative or end-of-life care services that is beneficial for citizens and preserves sustainability of the health care systems.

Scope

The complexity of health conditions related to life-threatening and chronic diseases, acute and chronic pain, late or long-term side effects as consequences of diseases and also their treatments affect quality of life of patients and their families and pose an immense societal and economic burden. Palliative and end-of-life care approaches improve quality of life of patients and professional and family caregivers through the prevention and relief of suffering by means of early identification, assessment and treatment of pain and other factors such as physical, psychosocial and spiritual problems. Although a variety of interventions are in use, they are often not adequately validated or adapted to the specific needs of patients affected by complex diseases or their co- or multi-morbidities. Therefore, a need exists to strengthen the evidence base for available patient-centred effective interventions improving quality of life and outcomes of patients of all ages in the domains of palliative and end-of-life care.

Proposals should address all of the following activities:

• Demonstrate the effectiveness and cost-effectiveness of newly proposed or specifically adapted pharmacological and/or non-pharmacological interventions to improve wellbeing and quality of life of patients suffering from life-threatening and chronic diseases (including disabilities). Whenever relevant, serious late and long-term side effects of disease treatments or symptoms that occur at the end of life of patients should be considered. The legal and ethical aspects of the proposed interventions should be taken into consideration and be fully addressed.
• Prove the feasibility of integrating the proposed interventions in current pain management, palliative and/or end-of-life care regimes and healthcare systems across Europe. The complex human, social, cultural and ethical aspects that are necessarily managed by those care regimes and healthcare systems should be reflected from patients’ as well as those of their professional and family caregivers’ perspectives. The views and values of patients and their caregivers (including families, volunteers, nurses and others) should also be appropriately taken into account in patient-centred care decisions.
• Identify and analyse relationships between sex, gender, age, disabilities and socioeconomic factors in health and any other relevant factors (e.g., ethical, familial, cultural considerations, including personal beliefs and religious perspectives, etc.) that could affect health equity to the proposed interventions, including equitable access.
• Analyse the barriers and opportunities to re-invigorating and enhancing timely social inclusion and active engagement of patients in need of palliative and end-of-life care and their caregivers.
• Provide implementation strategies and guidelines of patient-centred communication for health and social care professionals as well as standards for evidence-based communication trainings for caregivers, considering the potential of social innovation approaches or tools.
• When relevant, provide policy recommendations for pain management, psychological and/or spiritual support, and palliative or end-of-life care of patients.

Randomised clinical trials and observational studies, targeting different age groups, should be considered for this topic. Proposals should give a sound feasibility assessment, provide details of the methodology, including an appropriate patient selection and realistic recruitment plans, justified by available publications and/or preliminary results.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities. Proposals should consider a patient-centred approach that empowers patients, increase health literacy in palliative and end of life care, promotes a culture of dialogue and openness between health professionals, patients and their families, and unleashes the potential for social innovation.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, including internationally, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2023-CARE-04-03

Environmentally Sustainable and Climate Neutral Health and Care Systems

Indicative budget: € 20 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: environmental sustainability of healthcare; carbon emissions; resource management; hospital circularity; structural change; European Green Deal

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 4 “Ensuring access to innovative, sustainable and high-quality health care.” To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• Policy and decision makers, providers of health and care, health and care workers and citizens have increased knowledge on how today’s health and care systems are not environmentally sustainable, what the possible costs of that are (today and future) and where improvements are possible with maintained or improved quality of care (optimal patient safety not being jeopardised) and possible investments needed;
• Policy and decision makers and providers of health and care services have access to innovative solutions, organisational models (including financing models), and guidelines and recommendations that reduce the pollution and carbon emissions stemming from health and care systems, so that health and care provision can become more sustainable and cost-effective while maintaining or improving quality of care thanks to the reduction of energy and materials use, decreased carbon emissions, reduced waste and discharges, and efficient resource management;
• Monitoring and reporting of carbon emissions and pollution is mainstreamed through a life-cycle approach and with standard methods in the health and care systems.

Scope

The health care sector is responsible for 4-5% of global total carbon emissions, and generates significant demands for energy and materials, as well as dangerous waste streams that may cause air, soil and water pollution. At the same time, health and care provision generally experiences less pressure to decarbonise and improve its circularity than other sectors of the economy. With the European Green Deal, the EU commits to reducing net greenhouse gas emission by at least 55% by 2030, and to reach no net emissions by 2050, and the health and care systems are not exempt. Research and innovation can support by ensuring a smooth transformation while maintaining or improving quality of health and care services.

Health and care systems are undergoing structural changes, for example by strengthening primary care and community-based care, strengthening digitalisation and making sure patients are treated or cared for at the most efficient level. This offers the possibility to connect structural changes with an environmental transformation.

During COP26, 18 countries (including two EU Member States) have committed to cutting all carbon emissions from their health systems over the next 10 to 30 years and during the same period in total fifty countries (including six EU Member States) have committed to creating climate resilient, low carbon, sustainable health systems.

In February 2022, the WHO published a report on the waste that had been generated as a result of the COVID-19 pandemic, even more emphasising the need to improve waste management systems of the health and care systems. The report states that 30% of healthcare facilities word-wide, and 60% in the least developed countries, are not fit to handle the waste generated even when not taking the extra waste generated by the pandemic into account. Not only does this pose environmental risks such as water and air pollution, but it also poses a risk to health workers’ safety by increasing the risk of being exposed to stick injuries, burns and pathogenic microorganisms.

Research and innovation activities under this topic should be specific to health and care sectors. They should include cost studies when relevant (environmental impacts and benefits to be quantified through the life cycle thinking approach (e.g., LCA/SLCA), to be effectively implemented in line with the European Green Deal and the Zero Pollution Action Plan) and piloting research results onsite in hospitals or other care settings while generating accessible knowledge could be included. Apart from that, successful proposals should address several of the following:

• Research and innovative solutions for decarbonisation of hospitals and other care providers: improvements in new and existing building stock, decarbonisation of energy supply to premises, reduction in energy demand of hospital sites and other care facilities (for example heating and cooling, hot water, laundry, cooking, transport systems);
• Research and innovative solutions for increased circularity of hospitals or other care providers that integrate the zero-pollution ambition: such as solutions to reduce waste, improved waste management practices (with a possible focus on water effluents and Antimicrobial Resistance (AMR)), increased circularity (for example sustainable use of linen);
• Research and innovative solutions for decarbonisation and greening of supply chains and material inflows: reduction of single-use plastics, substitution of anaesthetic gases and inhalers with high global warming potentials (GWPs), substitution of conventional pharmaceuticals with green(er) alternatives, low-carbon supply chains of food, waste reduction, management models on for example prescription of pharmaceuticals;
• Development of a framework to measure and benchmark the environmental footprint of the health and care sectors or improving infrastructures for relevant collecting, sharing, accessing and processing of data.

Projects with interdisciplinary teams representing the health and care sectors, and the environmental sector or other relevant sectors are welcome.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. Therefore, proposals should include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase.

Applicants are encouraged to consider how their proposals can contribute in the context of the European Green Deal, and to take into account the principles of the Circular Economy Action Plan, the Zero Pollution Action Plan as well as the Technical guidance on the climate proofing of infrastructure in the period 2021-2027.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2023-CARE-08-01

European Partnership on Personalised Medicine

Indicative budget: € 100 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: personalised medicine; evidence-based policy; business modelling; healthcare sustainability; stakeholder, patient and public engagement 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 4, notably “Ensuring access to innovative, sustainable and high-quality healthcare.” To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• European countries and regions, along with international partners, are engaged in enhanced collaborative research efforts for the development of innovative personalised medicine approaches regarding prevention, diagnosis and treatment;
• Healthcare authorities, policymakers and other stakeholders develop evidence-based strategies and policies for the uptake of personalised medicine in national or regional healthcare systems;
• Health industries, policymakers and other stakeholders have access to efficient measures and investments to allow swift transfer of research and innovation into market;
• Health industries and other stakeholders can accelerate the uptake of personalised medicine through the adoption of innovative business models;
• Healthcare authorities, policymakers and other stakeholders use improved knowledge and understanding of the health and costs benefits of personalised medicine to optimise healthcare and make healthcare systems more sustainable;
• Healthcare providers and professionals improve health outcomes, prevent diseases and maintain population health through the implementation of personalised medicine;
• Stronger and highly connected local/regional ecosystems of stakeholders, including innovators, are in place and facilitate the uptake of successful innovations in personalised medicine, thus improving healthcare outcomes and strengthening European
  competitiveness;
• Citizens, patients and healthcare professionals have a better knowledge of personalised medicine and are better involved in its implementation;
• Stakeholders cooperate better and establish a network of national and regional knowledge hubs for personalised medicine.

Scope

Personalised medicine is a medical model using characterisation of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging and lifestyle data) for tailoring the right health strategy. Personalised medicine shows great promise and has already led to ground-breaking developments in treatment of many diseases. Through this approach, better health outcomes can be achieved by preventing disease and providing patient-centred care tailored to the needs of citizens. There have been important investments in personalised medicine over the last decades. However, producing knowledge, translating it into clinical applications and accelerating innovation uptake are complex, time-consuming and involve multiple stakeholders. There is a need to facilitate the uptake of health technology innovations and ensure a rapid and effective implementation of personalised medicine on a larger scale in Europe. To this end, the creation of a research and innovation (R&I) partnership with a focus on personalised medicine represents a unique strategic opportunity to bring together stakeholders, create synergies, coordinate R&I actions and leverage the efforts to accelerate the evolution of healthcare toward personalised medicine.

The partnership should build on knowledge gained from supportive initiatives like the International Consortium of Personalised Medicine (ICPerMed), the European Research Area Network for Personalised Medicine (ERA-PerMed), several Coordination and Support Actions (CSAs) funded by the EC under Horizon 2020, the one million genomes initiative as well as with an increasing number of associated and related initiatives, research infrastructures and capacities in Europe and beyond.

The partnership should facilitate exchange of information and good practices among countries, provide robust guidance and tools, will network institutional stakeholders and involve regional ecosystems. It should stimulate service, policy and organisational innovations, as well as the integration of biomedical and technological innovations for the benefit of the European citizens and the European industry. The partnership should bring together a broad range of actors with a common vision of future personalised medicine.

Through the objectives of Horizon Europe, the partnership should contribute to achieving the following European Commission priorities:

• Promoting our European way of life
• An economy that works for people
• A Europe fit for the digital age
• A European green deal

The partnership will also contribute to priorities of the “Communication on effective, accessible and resilient health systems” (COM(2014) 215 final), the “Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society” (COM(2018) 233 final) and the Europe’s Beating Cancer Plan.

Thanks to its capacity to bring together different stakeholders (e.g. research funders, health authorities, healthcare institutions, innovators, policymakers), to create a critical mass of resources and to implement a long-term Strategic Research and Innovation Agenda (SRIA), the partnership should address the following objectives:

• Putting Europe at the forefront of research and innovation through the support of multidisciplinary actions open to international cooperation;
• Establishing a European national and regional network of research and innovation systems dedicated to personalised medicine;
• Translating basic research into clinical applications that make a difference for patients, their families and healthcare professionals;
• Filling scientific knowledge gaps, producing evidence and developing guidance and tools in priority areas for the development and the deployment of personalised medicine;
• Integrating big data and digital health solutions in research and personalised healthcare;
• Strengthening the European healthcare industry and accelerating the uptake of personalised medicine solutions;
• Developing appropriate ecosystems for the implementation of successful personalised medicine approaches and a swift uptake of relevant innovations by healthcare systems;
• Providing socio-economic evidence of the feasibility of personalised medicine approaches for its uptake by sustainable healthcare systems;
• Improving health outcomes for citizen and patients and ensuring a wide access to advanced personalised medicine intervention approaches to all.

The European Partnership for Personalised Medicine is to be implemented through a joint programme of activities ranging from research to coordination and networking activities, including training, demonstration, piloting and dissemination activities, to be structured along the following main building blocks:

• Joint implementation of the SRIA;
• Joint annual calls for R&I activities, applied R&I, pilots;
• Capacity building activities;
• Activities to enhance the skills of the relevant personalised medicine workforce, and improve citizen relevant awareness and literacy;
• Deployment activities through pilots, innovation procurement and financial support mechanisms;
• Flanking measures.

The Partnership is open to all EU Member States, as well as to countries associated to Horizon Europe and will remain open to third countries wanting to join. It should include the following actors.

• Ministries in charge of R&I policy, as well as national and regional R&I and technology funding agencies and foundations;
• Ministries in charge of health and care policy, as well as national and regional healthcare
  authorities, organisations and providers.

The Partnership may also encourage engagement with other relevant Ministries and will involve other key actors from civil society and end-users, research and innovation community, innovation owners, healthcare systems owners/organisers and healthcare agencies.

The Partnership’s governance structure should enable an upfront strategic steering, effective management and coordination, daily implementation of activities and ensure the use and uptake of the results. The governance should leave sufficient space for involving the key stakeholders, including but not limited to R&I community, patients and citizens, healthcare professionals, formal and informal care organisations, and innovation owners.

Financial commitments and in-kind contributions are expected to be provided for the governance structure, the joint calls and other dedicated implementation actions and efforts for national coordination.

To encourage national coordination and avoid an excess of grant signatories it is recommended to limit their number to two per country. However, in duly justified cases this number could differ, including for countries with decentralised administration to allow for
participation of regional authorities in charge of R&I policy and health and care policy.

To ensure coherence and complementarity of activities and leverage knowledge and investment possibilities, the Partnership is expected to establish relevant collaborations with other European partnerships and missions as set out in the working document on ‘Coherence and Synergies of candidate European Partnerships under Horizon Europe’ as well as to explore collaborations with other relevant activities at EU and international level. On top of this, the proposal should consider synergies with EU programmes, including but not limited to EU4Health, DEP, ESF+, ERDF, InvestEU, RRF and TSI.

The Partnership should align with EU-wide initiatives on open access and FAIR data.

Cooperation with international organisations, and non-European institutions and experts should be considered. Applicants should describe in their proposal the methodology for their collaboration and the aims they want to achieve with this kind of collaboration.

Proposals should pool the necessary financial resources from the participating national (or regional) research programmes with a view to implementing joint calls for transnational proposals resulting in grants to third parties.

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HORIZON-HLTH-2023-TOOL-05-03

Integrated, multi-scale computational models of patient patho-physiology (‘virtual twins’) for personalised disease management

Indicative budget: € 50 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: patient modelling; complex disease progression; personalised diagnostics; virtual twin; Digital Europe 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society.” To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following expected outcomes:

• Clinicians and other healthcare professionals have access to and/or use validated multiscale computational models of individual  patients for delivering optimised and cost-effective patient management strategies superior to the current standard of care.
• Healthcare professionals benefit from enhanced knowledge of complex disease onset and progression by recourse to validated, multi-scale and multi-organ models.
• Clinicians and patients benefit from new, improved personalised diagnostics, medicinal products, devices, and therapeutic strategies tailored to the individual patient pathophysiology.
• Citizens and patients have access to validated ‘virtual twin’ models enabling the integration of citizen-generated data with medical and other longitudinal health data, and benefit from early detection of disease onset, prediction of disease progression and treatment options, and effective disease management.

Scope

This topic will contribute to the consolidation of existing virtual twin models and support research to move towards a more integrated human virtual twin, with the aim to accelerate translational research towards cost-effective development of new health technologies. Furthermore, ‘virtual twin’ patient models hold the potential of transforming clinical processes and healthcare with longitudinal monitoring, making personalised medicine, disease prevention and individualised patient management a reality.

Proposals are expected to contribute to the virtual human twin roadmap and ecosystem supported under the Digital Europe Programme, with models aligned and interoperable with those linked to the repository developed thereunder.

The proposals should address all of the following activities:

• Develop multi-scale and multi-organ, dynamic, interoperable, modular computational models, capable of accurately simulating the individual patient patho-physiology, spanning different anatomical scales, from the molecular to cell, tissue, organ and systems level, as necessary. Proposals should be multidisciplinary and focus on groups of communicable and/or non-communicable diseases with commonalities within the same or across different medical domains, including co-morbidities. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations towards citizen and patient benefit.
• Advance the state of the art in multi-scale modelling by employing diverse modelling methodologies, including but not limited to: mechanistic modelling, artificial intelligence, agent-based and network physiology as a means for modelling the healthy state, disease onset, progression, treatment and recovery. Availability of the necessary diverse data types (e.g. data from lab tests, medical imaging, wearables, sensors, medical check-ups, mHealth devices, longitudinal health monitoring etc.) should be demonstrated and the sex/gender dimension should be investigated.
• Integrate standardised spatiotemporal multi-scale models as a basis for developing personalised ‘virtual twin’ models taking account of patient individual characteristics, medical and health status history for advancing personalised disease management.
  Proposals should ensure that the development of ‘virtual twin’ models is driven by the end-users/citizens/healthcare professionals needs and their active involvement throughout the development process. Furthermore, applicants should utilise appropriate IT solutions for model visualisation and demonstrate their accessibility and usability for clinical uptake.
• Validate multi-scale patient-specific models and generate evidence that results can deliver clinically meaningful, real-world observations for the human diseases under study. Applicants should implement proof-of-concept, feasibility studies in relevant end-user environments and/or real-world settings, and collect evidence of utility vis-à-vis current clinical practice. Dynamic ‘virtual twin’ models and simulations as clinical decision support tools will need be shown to improve prognosis, medical diagnosis, treatments and health outcomes across the continuum of diseases evolution, including co-morbidities and long-term care as appropriate. An exploitation strategy and a business plan, including regulatory and industrial input, should be developed for accelerating clinical and/or market uptake.

The proposals should adhere to the FAIR data principles and adopt data quality standards, GDPR-compliant data sharing, access and data integration procedures based on good practices developed by the European research infrastructures. In relation to the use and interpretation of data, special attention should be paid to systematically assess for bias and/or discrimination (sex/gender, ethnic, minority and vulnerable groups aspects). Proposals are invited to consider adopting recommendations for in-silico models construction and validation.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2023-TOOL-05-04

Better integration and use of health-related real-world and research data, including genomics, for improved clinical outcomes

Indicative budget: € 35 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: health data integration; advanced digital tools; risk factors; evidence-based decision-making; personalised medicine 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society.” To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to most of the following expected outcomes:

• Researchers, innovators and healthcare professionals benefit from better linkage of health data from various sources, including genomics, based on harmonised approaches related to data structure, format and quality, applicable across certain disease areas and across national borders.
• Researchers, innovators, healthcare professionals and health policymakers have access to advanced digital tools for the integration, management and analysis of various health data re-used in a secure, cost-effective and clinically meaningful way enabling the improvement of health outcomes.
• By linking and using effectively more data and new methods and tools, including artificial intelligence, researchers, innovators and healthcare professionals are able to advance our understanding of the risk factors, causes, development and optimal treatment in disease areas where genomics integrated with other health data, spanning from clinical to e.g. lifestyle, offer potential for novel and more comprehensive information.
• Healthcare professionals and health policymakers benefit from data-driven solutions and reinforced evidence base for decisions addressing health and care challenges.
• Citizens can be offered data-driven patient-focused health interventions, resulting in improved disease prevention, diagnosis, treatment and monitoring towards better patient outcomes and well-being.
• Citizens’ trust in the sharing and re-use of health data for research and healthcare increases due to the application of advanced technologies and data governance preserving data privacy and security.

Scope

Health data bear vast information potential in many disease areas, to significantly improve the outcomes and efficiency of healthcare delivery, unlock new research and innovation avenues, and inform public health policy across Europe. There is a huge need of integration, use and deployment of health data from multiple sources for effectively addressing the challenges of medical research underpinning diagnostics, therapy guidance and implementation decisions on new therapies. Such integration requires linking data of different types, disease areas and provenance which are scattered in repositories and databases across Europe.

This topic aims to support proposals focusing on the integration of health data from multiple sources (e.g. electronic health records, genomics, medical imaging, laboratory and diagnostic results, pathogen data, public health registries and other clinical research data) by linking real-world and clinical research data. The data integration should be exemplified in several use cases, i.e. well-justified groups of diseases (excluding cancer), within and/or across medical domains, and pave the way towards improved health outcomes. At least one of those use cases should build on the use of whole genome sequence data.

The consortium should ensure wide coverage of EU and associated countries, contributing significantly to health data standardisation, while catering for the diversity of health data sources.

To enhance synergies and avoid overlaps of activities, the proposals are expected to align with and complement the relevant European initiatives, in particular the European Health Data Space (EHDS), the 1+Million Genomes initiative (1+MG) and the European Open Science Cloud.

The applicants have to demonstrate that the necessary data sources are, or will be, effectively, timely and legally available for the proposed research activities.

The proposals should address all of the following activities:

• Identification of the barriers to health data integration and access as needed for the selected use cases, and of specific existing tools, technological solutions and coordination and standardisation agreements addressing those barriers. Issues to be covered include semantic ontologies, data standards and formats, data quality, data storage, management and access modalities, as well as enhanced findability of relevant datasets through improved metadata standards and data catalogues.
• New approaches to assemble large, easily findable and lawfully accessible high-quality datasets integrating multiple types of health data leading to improved clinical outcomes (e.g. new care solutions, personalised disease management, advanced diagnostic tools), taking into account data FAIRification and inter-operability needs.
• New techniques, support tools, mechanisms and modalities to enable GDPR compliant access to sensitive personal data, including genomics, allowing for their re-use across borders and integration of different types of data relevant to human health. Legal and
  ethical frameworks should duly consider the heterogeneity in national and sectorial rules and procedures for data access and re-use.
• Data management approaches for cross-border distributed data storage and processing, enabling remote collaboration, electronic consent management, data provenance tracking, and scalability of data management resources, ensuring data privacy and security, and resulting in robust support to advanced, innovative clinical workflows. Joint data governance is expected to be piloted among several clinical centres across Europe.
• Development of a data analytics platform applying distributed learning and artificial intelligence approaches to query and aggregate efficiently, effectively and securely data from multiple sources for multiple use cases (groups of diseases), to monitor patients’ health status, analyse causal inference, support diagnosis and health policymakers, and establish recommendations for patients and other stakeholders.

The proposals should adhere to the FAIR data principles and build on existing and justified tools and harmonisation efforts, such as widely used standards for encoding the different types of health data and inter-operability for cross-sector collaborations. Also the data collection, management and/or modelling should build on ongoing EU and international efforts to avoid possible duplication of efforts and fragmentation. In particular, projects are expected to take into account the legislation, if available, on the EHDS, so as to align project activities with pertinent EHDS infrastructure efforts that provide for the secondary use of health data as regards e.g. cross-border access to data, cross-border infrastructures, data quality and utility labelling. The achievements of the relevant past and ongoing EU-funded projects and initiatives, and good practices developed by the European research infrastructures, should be duly considered and used. Close involvement of patients and end users is crucial to ensure that the project outcomes are relevant, widely accepted and feasible in real-world settings.

The tools developed by the projects are expected to be widely accessible and amenable to necessary updates after the project’s end for further use by interested parties. Datasets generated during the project should be accessible to researchers and innovators. For example, genomic data and linked patient level data are expected to be made accessible for secondary use through the 1+MG data infrastructure.

This topic requires an effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage.

The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2023-TOOL-05-05

Harnessing the potential of real-time data analysis and secure Point-of-Care computing for the benefit of person-centred health and care delivery

Indicative budget: € 35 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: advanced data processing; continuous monitoring; gender specificities; advanced imaging; robotics; patient safety; reduced energy consumption 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society.” To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to all of the following expected outcomes:

• Healthcare professionals benefit from secure, highly performant Point-of-Care computing technologies and devices able to process and analyse vast amounts of real-time data at the point of care, combined with extended reality and visualisation techniques, to enable continuous monitoring and/or fast real-time health status checks in clinical settings and workflows.
• Patients and clinicians benefit from wider access to real-time diagnosis, screening, monitoring and treatments using novel imaging and/or robotics systems and/or Point-ofCare devices that are seamlessly integrated in care environments and workflows.
• Quicker reaction times and improved patient safety in care settings.
• Researchers and healthcare professionals have more opportunities to use, extract value from and contribute to the uptake of real-time health data and/or Point-of-Care computing; existing technologies and methods are expected to progress from their current technology readiness levels (TRL), from TRL 3-4 to at least TRL 7247.
• Health and care settings benefit from reduced energy consumption of Point-of-Care tools, devices and systems, and/or data analysis.

Scope

The proposals are expected to develop and test innovative tools, devices and systems for point-of-care applications, including but not limited to robotics, photonics, bio-sensing, artificial intelligence etc. These would provide clinicians with real-time imaging, data analysis and interactive visual presentation for understanding and diagnosing diseases, facilitating risk assessment, prevention, and carrying out medical interventions with improved patient safety. The proposals should demonstrate advancement and integration of technologies from proofof-concept to prototype demonstration in operational environment. Devices and systems should be designed, developed and tested vis-à-vis defined use cases, based on the appropriate involvement of clinicians and other stakeholders, ensuring they can be seamlessly integrated into existing digital infrastructures and clinical workflows. The use cases in care settings could include but are not limited to surgery workflows, Intensive Care Unit workflows and integration of remote patient monitoring into clinical workflows. Data quality, integration and interoperability, as well as issues of cybersecurity and data protection have to be addressed. Design should take gender specificities into account. Clinical studies should be an integral part of the work proposed, with developmental iteration steps and consultation of regulators included as appropriate. Establishing synergies with AI Testing and Experimentation Facilities, European Digital Innovation Hubs and other similar initiatives is encouraged. Proposals must include a short description of initial business plan as part of the exploitation activities.

The proposals should address all of the following activities:

• Development and clinical validation of compact, cost- and energy-efficient, extended reality-enabled and other Point-of-Care devices and systems, with fast/real-time response times as required, reliable and capable of integration into clinical settings and workflows.
• Development and validation of instruments, continuous monitoring systems and/or analysis algorithms, including artificial intelligence approaches, for the analysis of biological samples, enabling detection of biomarkers in body fluids and tissues in clinical settings.
• Development and validation of imaging systems with a high spatial resolution down to the cellular level allowing for immediate clinical interventions. Single imaging modalities or the combination of different imaging modalities should be made compatible with other imaging tools and with state-of-the-art and/or novel medical technologies and devices, for example those used to remove tissues in precision surgery (e.g. robotic surgery).
• Advancements in the use of Point-of-Care computing, data modelling, extended reality and/or machine learning/AI technologies applied to diagnosis and risk assessment in cases requiring very fast, near to real-time response times in clinical settings and workflows. In addition, projects should showcase how distributed systems bringing computation and storage physically close to where data is generated and used can most effectively deliver actionable outputs for person-centred health care, contributing to
  improved patient safety, in the areas of for example healthy living support, remote patient monitoring, surgery workflows or acute care.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2024-TOOL-05-06-two-stage

Innovative non-animal human-based tools and strategies for biomedical research

Indicative budget: € 25 million
Opening: 30 March 2023
Deadline(s): 19 September 2023 (first stage) 11 April 2024 (second stage)

Keywords: human-relevant tools; non-animal-based research; disease prediction and treatment; advanced tools 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society.” To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following expected outcomes:

• Researchers utilise tools and strategies that are more relevant to the human situation as compared to the currently used animal models.
• Fewer live animals are used in biomedical research.
• Health technology developers will get access to improved human-relevant tools or strategies allowing for a faster pace of innovation.
• Legislators and regulators will benefit from strengthened EU leadership in non-animal based biomedical research that is socially accepted and sustainable.
• Healthcare providers and patients will benefit from innovative tools or strategies opening up novel biomedical concepts enabling improved disease prediction, prevention and treatment.

Scope

The proposal(s) should develop and/or use tools and strategies that address critical areas of biomedical research where animal-models are currently used but are of limited translational value for investigation and development of prevention and treatment. Such advanced tools and strategies should aim at a better understanding of the pathogenesis of disorders that feature a high impact on public health and exhibit a high rate of animal use or severe animal suffering, and enable to develop biomedical concepts with increased translational value, thereby ultimately leading to improved disease prediction, prevention and treatment.

The proposals should address all of the following aspects:

• The innovative tools and strategies should include a variety of technologies and methodological approaches such as –omics and other high-throughput procedures, human-derived cell-based material, organoids, micro-physiological systems, and insilico models.
• The newly proposed tools and strategies should demonstrably advance the state-of-theart in specific areas of biomedical research.
• Prospects and avenues for dissemination, knowledge sharing, uptake or translation into health policies of the proposed tools and strategies within the EU should be provided.
• Aspects such as harm and cost-benefit assessment as well as ease of production with respect to current practices should also be considered.
• Criteria for model qualification and standardisation should be developed in well-justified use-case contexts to demonstrate their translational values.

Proposals could consider the involvement of the European Commission’s Joint Research Centre (JRC) to provide added-value regarding such aspects as supporting validation of emerging approaches, promotion of research results, and the interfacing with the regulatory community. In this respect, the JRC is open to collaborate with any successful proposal after the selection process has been completed.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2023-IND-06-07

Development and harmonisation of methodologies for assessing digital health technologies in Europe

Indicative budget: € 15 million
Opening: 12 January 2023
Deadline(s): 13 April 2023

Keywords: digital health technology assessment; citizen empowerment; personalised digital technology; technology specifications; mhealth

Expected Outcome

This topic aims at addressing digital transition challenges through supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry.” More specifically, this topic aims at supporting activities that are contributing to the following impact area: “High quality digital services for all.” To that end, proposals under this topic should aim to deliver results that are directed towards and contributing to all of the following expected outcomes:

• Policymakers in the EU have at their disposal a methodological framework and standardised approaches for assessing digital health technologies, that helps them make evidence-based decisions regarding the introduction of digital health technologies in their health and care systems with added value for patients and society.
• Regulators have access to robust, scientifically underpinned evaluation methodologies.
• EU citizens gain faster access to safe and well-performing person-centred digital technologies and are empowered through these tools.
• Health technology developers are better informed and dispose of more guidance on the evidence needed to demonstrate the added value of digital health technologies and have better insights on market predictability.
• (Digital) Health Industry/digital health technology developers and HTA bodies can contribute to the development of EU harmonised Health Technology Assessment (HTA) rules based on common principles.
• Improved cross-border use and interoperability of digital health tools and services throughout the EU and Associated Countries.
• Increased trust in digital health technologies and better integration of digital health tools and services in health and care systems.

Scope

Digital health technologies have been driving a revolution in health and care ranging from general use of computers to algorithms designed to assist radiologists and radiotherapists in detecting and treating diseases, from robotic surgery to artificial intelligence, machine learning, computer aided decision models, and from mobile apps helping patients to selfmanage their disease to electronic health records.

Digital health technologies are expected to further contribute to better people-centred health and care systems and have the vast potential to improve our ability to accurately prevent, diagnose and treat diseases.

However, assessing the added value and health benefits for patients and society pose a number of challenges in particular of methodological and technical nature. Best practice for common approaches in methodology for digital health are lacking, especially in the digital health tools that include artificial intelligence algorithms. A framework for the assessment of the digital transformation of health services and its impact is vital to generate the evidence required for decision-making on stimulating, using and/or funding digital health strategies at various levels in the health and care systems.

The Expert Panel on effective ways of investing in Health (EXPH) recommended in its report ‘Assessing the impact of digital transformation of health services’, further investment in the development of assessment methodologies and in a European repository for evaluation methods and evidence of digital health services.

To date, such assessment frameworks are relatively scarce, especially those addressing the transformative aspects of healthcare delivery on the organisational and operational level.

The proposals are expected to develop and harmonise methodologies for assessing digital health technologies (including m-health apps and telehealth, as well as Artificial Intelligence powered health technologies) in order to facilitate assessment of their added value at
individual, health system and society levels and facilitate the cross-border deployment of digital health services within the EU. Existing Health Technology Assessment (HTA) methodology is well developed for health technologies such as medicinal products, but also for some categories of medical devices; however digitalisation raises new methodological challenges to the standardisation of assessment criteria such as privacy, cybersecurity, data storage and handling, interoperability, usability etc. Also including aspects like learning curves, iterative development of innovations, variability between settings, determining optimal timing of evaluations in the development process (maturity) are not yet solved.

Proposals are expected to build on existing frameworks such as (but not restricted to) ‘Model for Assessment of Telemedicine’ (MAST framework – Kidholm et al., 2012) and the results of previous EU-funded projects in particular (but not restricted to) COMED, project that
already identified HTA challenges of telehealth and mhealth, and mHealth hub.

Proposals should consider involving the JRC to take advantage of its expertise on assessment frameworks of innovative health technologies and its activities at the interface between research and regulatory aspects and/or in translating assessment results into best practice recommendations anchored in EU policies. In that respect, the JRC is open to collaborate with any successful proposal after its approval.

The proposals should address all of the following activities:

• Develop and/or expand a general methodological framework and standardised approaches to assess digital health technologies with a particular focus on criteria such as privacy, cybersecurity, data quality, data storage and handling, interoperability etc.;
• Comply with the relevant requirements proposed in the European Health Data Space (EHDS) legal provisions;
• Test the robustness of the developed methodologies on minimum 3 different digital health technology use cases;
• Pilot the development of common specifications to the harmonisation of assessment frameworks (pre-market and post-market phases) throughout the EU and Associated Countries;
• Include end-users of digital health technologies (be it professionals, care users or citizens), developers of digital health technologies, producers of health services, regulators and governments;
• Collect best practice for common approaches in methodology for digital health technology assessment and develop an open access European repository for evaluation methods, studies, results and evidence of digital health technologies and services;
• Contribute to a framework to evaluate and monitor whether the uptake and use of digital health services contribute to the overall goals of the health and care system;

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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HORIZON-HLTH-2024-IND-06-08

Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs)

Indicative budget: € 10 million
Opening: 26 October 2023
Deadline(s): 11 April 2024 (second stage)

Keywords: innovative medical devices; Medical Device Regulation; clinical evaluation; harmonised technology assessment; real-world data integration 

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry.” To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

• Patients gain faster access to innovative, safe and well-performing medical devices;
• Regulators have access to sound scientific resources for clinical/performance evaluation guidance and development of common specifications as foreseen in Article 9 of the Medical Device Regulation (MDR);
• Notified bodies, by their direct participation to the production of documents, will have a harmonised way of assessing the clinical evidence in the pre-market and post-market phases; furthermore their network, will be enhanced;
• Health technology developers gain insight on the evidence needed to demonstrate that their devices meet MDR clinical requirements throughout their lifetime. They will also have more guidance on the use of real-world data for their clinical development strategies.

Scope

The Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) provides a new regulatory framework where reinforcement of clinical/performance evaluation of medical devices and IVDs, and in particular high-risk medical devices, is a key element. The confirmation of conformity with the relevant general safety and performance requirements set out in the MDR and IVDR is based on clinical data and its assessment (clinical/performance evaluation), including the evaluation of the acceptability of the benefit-risk- ratio. Within this new framework, the clinical/performance evaluation should follow a defined and methodologically sound procedure based on the critical evaluation of the relevant scientific literature, a critical evaluation of the results of all available clinical investigations/performance studies, as well as consideration of currently available alternative treatment options for the device under evaluation. Clinical/performance evaluation has to be updated throughout the life cycle of the device. Hence, clinical/performance evaluation can draw on multiple types of data including data from initial clinical investigations/performance studies and data gathered by the manufacturer’s post-market surveillance system. To operationalise this new requirement, research is needed to help regulators develop common methodological frameworks (including common specifications) on the clinical evidence needed to demonstrate safety, performance and clinical benefit all along the life cycle of devices taking into account the type of device and clinical intended purpose. Such methodological frameworks and standardised approaches are particularly needed for high-risk medical devices, e.g. implantable and class III medical devices, class C and D IVDs, medical device software (including AI enabled devices and next generation sequencing) and other highly innovative devices. In order to address the differences between evidence generation for medical devices and IVDs, the project should be tackled taking into account those differences. Proposals should address all of the following activities:

• Development of a framework for a life-cycle approach to evidence generation and evaluation of high-risk and innovative medical devices and IVDs. This framework will provide a description of the types of evidence i) that meet safety and performance for market access, and ii) that have to be generated to fulfil post-market responsibilities.
• When appropriate it would be beneficial to consider to what extent the framework could be relevant to demonstrate relative effectiveness as needed for Health Technology Assessment. As regards highly innovative devices, particular attention may be paid to defining acceptable levels of uncertainty in terms of benefit-risk ratio at market entry as well as the type of post-market follow-up to be implemented to generate additional clinical evidence able to reduce this uncertainty. This could be particularly relevant for devices e.g. having no or little similarities with existing devices in terms of intended purpose, mode of action, materials or, for IVDs, with no existing reference materials.;
• For medical devices, a pilot to support development of common specifications which would set the stage for a common specification ecosystem for medical devices in the EU, including the development of standardised/common endpoints and associated health outcomes measures by technology type and where relevant by clinical intended purpose;
• Development of a general methodological approach to define, determine and update the state of the art for different device technologies. The robustness of the developed approach should be evaluated on 3 different medical device types and 3 different IVD types;
• Possible use of registries and other sources of real-world data for demonstration of regulatory compliance both pre- and post-market: minimum requirements for data quality, completeness and data reliability, statistical methods for data analysis, methods for limiting biases, methods for data linkage, determination of what acceptable evidence can be drawn from registries;
• Methodology for bridging studies for devices and IVDs with iterative development: assessment of data coming from previous versions of the device and where relevant integration of that data into the device’s clinical investigation/performance study and gap assessment between the different versions of the device;
• Identification of relevant quantitative and qualitative methodologies for integrating evidence derived from various data sources in the clinical evaluation/performance evaluation;

Proposals should build on relevant completed and ongoing initiatives in the field, in particular (but not restricted to) EU-funded initiatives. Proposals should involve researchers who are specialised in the clinical/performance evaluation of medical devices/IVDs and in the use of real-world data to evaluate medical products. Proposals should involve national competent authorities, notified bodies, IVD laboratories as well as Health Technology Assessment bodies and could involve patients’ representatives where relevant. Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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DP-g-23-31-02

Call for proposals to support stakeholders on the prevention of NCDs in the area of chronic respiratory diseases

Indicative budget: € 1 million
Opening: Q2-Q3 2023
Deadline(s): TBD

Keywords: noncommunicable diseases; chronic respiratory diseases; public health; Beating Cancer Plan 

Expected Outcome

The action will implement projects on health promotion and disease prevention, and is expected to support the Member States’ efforts to reduce the burden of NCDs (approximately 80% of the disease burden in Europe), in particular that related to CRDs, and to reach the Sustainable Development Goal 3, in particular target 3.4.

The expected results will include initiatives to complement the Member States’ efforts in the design, planning and implementation of best practices, such as for the development of public health guidelines, patient pathways, and support for the preparation and roll-out of new policy approaches, participation in the pilot testing of innovative practices, development of support actions such as training and improving health awareness and health literacy.

Scope

The aim of this action is to complement the implementation of the joint action “DP-g-23-31-01 ‘Healthier Together’ EU NCD Initiative – Chronic respiratory diseases” led by the Member States, thus helping to reduce the burden of CRDs in the Union, both at personal and
population level, targeting or addressing the related risk factors and their determinants, as necessary.

The activities will cover the prevention and management of CRDs and will complement the joint action. Activities will include implementing projects involving civil society organisations to support the Member States’ authorities in the implementation  of comprehensive public health policies, the development and transfer of best practices, the development of public health guidelines, the preparation and roll-out of innovative approaches, projects supporting patient pathways and the launching of projects expected to have a significant public health impact and which benefit citizens directly. These may include projects to support the Member States in meeting the objectives of the Zero Pollution Action Plan82, the Chemicals Strategy for Sustainability83 and of the Europe’s Beating Cancer Plan.

Activities should also include an equity dimension and aim at reducing health inequalities.

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CR-g-23-44-01

Call for proposals to support the implementation of the strategic agenda for medical ionising radiation applications (SAMIRA95) – organisation of clinical audit campaigns as a tool to improve the quality and safety of medical applications of ionising radiation

Indicative budget: € 1.5 million
Opening: Q2-Q3 2023
Deadline(s): TBD

Keywords: clinical audit; medical radiation; accreditation and certification; Basic Safety Standards Directive; radiology; radiotherapy; nuclear medicine

Expected Outcome

The action will contribute to a better implementation of the BSS Directive’s requirement with regard to clinical audit taking into account the differing challenges across Member States. It can serve as a reference action to establish a permanent clinical audit mechanism in some Member States.

It will improve the overall quality and safety of radiological medical procedures in order to bring their full benefits to patients. It will contribute to the development of the professional skills of the auditors and of the audited professionals and foster inter-disciplinary and multi-professional relationships. It should contribute to the development of leadership in this area.

This action could also strengthen structures involved in hospital accreditation or individuals involved in professional healthcare certification schemes. The pilot outcomes should be relevant to health systems as a whole and be designed in a way that their outcomes can be scaled up into the broader health system practice of the Member State(s).

Scope

The objective of this action is to pilot clinical audit campaigns in Member States in diagnostic and interventional radiology, radiotherapy and nuclear medicine by identifying and bringing together relevant actors and resources. It should take into account the specificities of the national health systems. It will include coordination, planning, recruiting, training, auditing and reporting activities. It should build on the results of the QuADRANT and the EU-JUST-CT project.

Up to four proposals of different sizes will be accepted, ranging from organising pilot audits in a single (large) department or hospital, a hospital trust, a region or a single Member State to coordinated audits in several Member States and should be implemented in coordination with the appropriate health authorities. A priority will be given to proposals covering several types of medical practice in several Member States and also to different practices within different regions of a Member State. Proposals should include considerations and activities to scale up pilot outcomes into the broader health system practice of Member State(s).

In particular, the clinical audit action should seek to improve justification of radiological imaging, in line with the 2015 Council conclusions on this topic98, and the implementation of the optimisation principle. The action will be implemented in close cooperation with other SAMIRA activities on quality and safety of medical applications of ionising radiation and include a reporting on the pilots carried out in Member States to the SGQS.

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CR-p-23-41

Development of EU guidelines and quality assurance scheme for lung, prostate and gastric cancer screening

Indicative budget: € 7.5 million
Opening: TBD
Deadline(s): TBD

Keywords: cancer screening; lung, prostate, gastric cancer; quality assurance; health guidelines

Scope

On 20 September 2022, the Commission adopted a proposal for a Council Recommendation on strengthening prevention ‘A new EU approach on cancer screening’ replacing Council Recommendation of 2 December 2003 on cancer screening 2003/878/EC119. In addition to the cancer screening programmes for breast, colorectal and cervical as recommended under the 2003 Council Recommendation, the Commission proposal recommends screening for lung, prostate, and under certain conditions, gastric cancer. Through the Commission initiatives on Breast and Colorectal Cancer, a system and methodology for the development of EU guidelines for cancer screening and treatment including also a Quality Assurance Scheme, has already been developed. Based on this existing methodology, guidelines for the screening of lung, prostate and gastric cancers will be developed as indicated in the Commission proposal for the Council Recommendation. The guidelines will be complemented by quality assurance manuals and tools to help the implementation and monitoring of their use in the Member States to support the further design, planning, and implementation of population-based and targeted cancer screenings, diagnosis and treatment.

This action supports the implementation of Europe’s Beating Cancer Plan and implements the EU4Health Programme’s general objective of improving and fostering health in the Union (Article 3, point (a) of Regulation (EU) 2021/522) through the specific objectives defined in
Article 4, points (a) and (i), of Regulation (EU) 2021/522.

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CR-p-23-44-02

To support the implementation of the strategic agenda for medical ionising radiation applications (SAMIRA) – study on the implementation of the EURATOM and the Union legal bases with respect to medical devices used in medical applications of ionising radiation

Indicative budget: € 300,000
Opening: TBD
Deadline(s): TBD

Keywords: medical devices; radiation protection; legal implementation 

Scope

A variety of nuclear and radiation technologies play a key role in the fight against cancer. Mammography, computed tomography and other forms of radiological imaging are indispensable technologies for all stages of cancer management. Radiotherapy is among the most effective, efficient and widely used cancer treatments available to patients and physicians. Nuclear medicine is routinely used for cancer diagnosis and follow-up, and increasingly available for cancer treatment. Medical applications of ionising radiation are constantly evolving in a complex regulatory environment and there is scope to improve coordination in implementing the different regulatory frameworks. This is the case with regard to medical devices used in medical applications of ionizing radiation that are subject to the EU medical devices and the Euratom radiation protection legislations, both setting requirements for installation and acceptance testing, reporting of adverse events, and other indicators. The results of the work will underpin further efforts to improve the coordination between the two legal bases and support their efficient implementation for the benefit of patients. This action supports the implementation of Europe’s Beating Cancer Plan and implements the EU4Health Programme’s general objective of improving and fostering health in the Union (Article 3, point (a) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (a) and (h), of Regulation (EU) 2021/522.

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EU4H-2022-PJ-11

Call for proposals on prevention of NCDs – cardiovascular diseases, diabetes and other NCDs

Indicative budget: € 5 million
Opening: 15 September 2022
Deadline(s): 28 February 2023

Keywords: noncommunicable disease; EUNCD; best practices; public health guidelines; innovation 

Expected Outcome

The action will contribute to the implementation of projects on disease prevention and health promotion, which are expected to reduce the burden of NCDs, namely diabetes and cardiovascular diseases in Member States.

The expected results will include initiatives to complement the Member States’ efforts in the design, planning and implementation of best practices, such as support for the development of public health guidelines, support for the preparation and roll out of new policy approaches; participation in the pilot testing of innovative practices; development of support actions such as training and twinning, health communication or health literacy; and implementation of best practices in health promotion and disease prevention. The short-term impact will be an increased number of public health interventions being scaled up in all Member States and improvements in disease prevention and health promotion, and management policies relatedto NCDs.

Scope

The aim of this action is to reduce the burden of NCDs and related risk factors, targeting:

a) Cardiovascular diseases and diabetes, both at an individual and societal level, namely by supporting the NCDs policies and corresponding actions led by the Member States;

b) NCDs other than the five action strands of the initiative ‘Healthier Together – EUNCD Initiative’ and cancer; such as chronic kidney diseases and liver diseases, auto-immune diseases, musculo-skeletal conditions, etc.

This action will complement the Member States’ joint action on ‘Prevention of NCDs -Cardiovascular diseases and diabetes’ (DP-g-22-06.03) that aims to contribute to reducing the burden of NCDs, i.e. cardiovascular diseases and diabetes, and related risk factors, both at apersonal and societal level, including the health inequalities dimension.

The civil society organisations will implement targeted projects and activities, complementing the Member States’ efforts in the design, planning and implementation of best practices, including support to the definition of public health guidelines, to the preparation and roll out of new policy approaches, to the pilot test of innovative practices, and to support actions such as training and twinning, health communication or health literacy. Activities should also include an equity dimension and aim at reducing health inequalities.

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EU4H-2022-PJ-12

Call for proposals on cancer and other NCDs prevention – action on health determinants

Indicative budget: € 11 million
Opening: 15 September 2022
Deadline(s): 28 February 2023

Keywords: Beating Cancer Plan; Farm to Fork Strategy; HealthyLifestyle4All; best practices; public health guidelines; health inequalities

Expected Outcome

The action will implement projects on disease prevention and health promotion, which isexpected to reduce the burden of cancer and other NCDs in the Member States.

The expected results will include initiatives to complement the Member States’ efforts in the design, planning and implementation of best practices, such as support for the development of public health guidelines and, support for the preparation and roll out of new policy approaches; participation in the pilot testing of innovative practices; development of support actions such as training and twinning, health communication or health literacy; and implementation of best practices in health promotion and disease prevention.

The short-term impact will be an increased number of public health interventions being scaled up in all Member States and improvements in disease prevention and health promotion, and management policies related to cancer and other NCDs.

Scope

The aim of this action is to complement the implementation of the joint action on ‘Cancer andother NCDs prevention – action on health determinants’ led by the Member States, thus helping to reduce the burden of cancer and other NCDs, and related risk factors, both at a personal and societal level, namely by supporting the Europe’s Beating Cancer Plan andpolicy initiatives on NCDs. It may also support other Union initiatives that aim to improve public health such as the Farm to Fork Strategy and the HealthyLifestyle4All initiative in so far as it shares the objectives of promoting sustainable food consumption and facilitating the shift to healthy, sustainable diets and promoting a healthy lifestyle.

Activities will run in parallel to the joint action, include implementing targeted projects involving civil society organisations complementing the Member States’ efforts in the design, planning and implementation of best practices, the production of public health guidelines, patients’ and caregivers’ consultations, or other actions that can benefit citizens directly, the preparation and roll out of innovative practices (pilot test), and support actions such as training and twinning, health communication or health literacy. The activities include provision of input via the Health Policy Platform, namely as regards their role inimplementation.

Activities should also include an equity dimension and aim at reducing health inequalities.

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EU4H-2022-PJ-14

Call for proposals to support the roll-out of the second cohort of the inter-speciality cancer training programme

Indicative budget: € 7 million
Opening: 15 September 2022
Deadline(s): 28 February 2023

Keywords: trustworthy AI tools, risk prediction, chronic non-communicable diseases, evidence-based recommendations and guidelines

Expected Outcome

The action will increase the coverage of the inter-speciality cancer training programme across the Union, and will result in the upskilling and re-skilling of healthcare professionals in the areas of clinical oncology, surgery, radiology and radiation technology, and nursing and other specialised services, with an increase in the number of training centres engaged in the initiative, as well as trainees and trainers. This action will help Member States to improve cooperation among their cancer services, by addressing skill gaps and better equipping the health workforce with personnel trained in cancer care.

Scope

The aim of this action is to extend the implementation coverage of the first cohort of the inter-speciality cancer training programme through enrolling new cancer centres, as well asadditional trainees and trainers.

The action will roll-out the second cohort of trainees and, in addition, will organise a dissemination event to present the outcomes of the training. The action is expected to be complemented by the organisation of events to share the experiences developed during the training, which will also strengthen the networking of the trainees and trainers across the Union.

Specific activities will include a selection process for the trainees, trainers, and cancer centres which will participate in the inter-speciality cancer training programme. The programme is expected to train medical doctors and nurses and other specialised staff (such as thoseinvolved in medical imaging and radiation oncology including radiation technologists, medical physicists, radiobiologists, etc…) working in cancer centres in the three specialties of clinical oncology, surgery, radiology and radiation oncology with the aim of optimising the inter-speciality approach and cooperation. The training will be based on curricula previously developed ad hoc for the action and will include technology-based learning, simulations, and on-the-job training. The training programme will follow a coaching and mentoring approach with regular reporting and assessment of skills and tasks developed; case studies will be part of the training programme.

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EU4H-2022-PJ-15

Call for proposals to support structured dialogue at national or regional level on public procurement in the health sector – HERA

Indicative budget: € 5 million
Opening: 15 September 2022
Deadline(s): 28 February 2023

Keywords: public procurement; supply chain; healthcare resilience; cross-border threats

Expected Outcome

The action is expected to result in the development of new or improved national and regional strategies on public procurement that will make current practices more resilient and efficient all over the Union. This will increase preparedness for future health crises.

The involvement of Member States at national, regional and/or local level as well as of all relevant stakeholders by using collective intelligence methods will also increase coordination and more and better cooperation for the future

Scope

Specific mandatory deliverables and/or milestones

A high coverage of MS is encouraged in the proposal, noting that the total budget of the call was established to conduct such work ideally in around 12 Member States.

Minimum activities that should be covered by the proposal:

Mapping of the public procurement environment in the health sector in the Member States covered by the project including:

– Mapping of purchases made by central purchasing bodies or hospitals, bound by EU public procurement rules. Concretely, a mapping should be made of who is buying what, from whom, and how? This will allow to understand not only the concrete needs public buyers have, but also to set concrete objectives, such as ensuring the security of supply chain, ensuring more innovative and sustainable purchases, etc.

-Mapping of all relevant stakeholders involved.

– Mapping to be done in a format that can be easily used for statistics, data gathering, graphics.

Listing of relevant thematic topics to organise the work (preliminary topics should be mentioned in the proposal) and facilitate exchanges, gather opinions and draw lessons learned, on the basis of the above mentioned mapping.

Organisation of brainstorming sessions, dialogues or additional work arrangement on the different thematic topics identified by way of collective intelligence with the involvement of all stakeholders and decision makers. Reports on the assessment of the outcomes of those brainstorming working sessions on each of the thematic topics discussed including a first draft of recommendations and which will form the basis for an overall strategy on public procurement for/by hospitals who are bound by public procurement rules.

New strategies for public procurement in health sector tailored to the needs of the Member State or region concerned as well as an implementation plan based notably on:

– Discussion of all recommendations in order to develop up a first draft national/regional strateg(y)ies with the involvement of all stakeholders and decision makers,

– Exchange between the consortia from different awarded projects in order to draw and share lessons learned in and within Member States,

– Discussion and finalisation of draft strategy(ies) at national and/or regional level as well as an implementation plan at national and/or regional level.

Dissemination of the results of the project in a final conference with a European dimension. While preparing the conference, results of the activities carried out under the same call for proposals shall be covered to cross-fertilise results among projects.

During the entire project, selected consortia are encouraged to cooperate with one another. Thereto, it is expected they will include in their proposals the possibility to organize common meetings, for example a kick-off that could be organised by the Commission for all the awarded projects.

Specific action-level indicators for reporting purposes

– Number of stakeholders included in the mapping (i.e. outreach of the activity)

– Number of information products (e.g. data, statistics, graphical representations etc) stemming from the mapping

– Number of key stakeholders identified by topic (i.e. stakeholders’ mapping)

– Number of events (e.g. brainstorming sessions, dialogues etc.) organized by topic

– Number of participants to the events by topic and by country

– Number of stakeholders involved in the reflection on public procurement strategies, by topic, by type (Member States, beneficiaries, health care entities etc) and by country

– Number of stakeholders endorsing the recommendations/strategies produced, by topic, by type (Member States, beneficiaries, health care entities etc) and by country

– Number of participants to the project conference by type and by country

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IHI-03-01

Screening platform and biomarkers for prediction and prevention of diseases of unmet public health need

Indicative budget: € 6–8 million
Opening: 13 December 2022
Deadline: 15 March 2023

Keywords: biomarkers; unmet public health needs; cost-effective interventions; advanced analytics; artificial intelligence

Expected Outcome

R&I actions (projects) to be supported under this topic should aim to deliver results that contribute to all of the following expected outcomes for disease(s) of high unmet public health need selected by the applicants¹:

• Patients will receive earlier or more timely interventions (prevention, early treatment to avoid complications, etc) to reduce morbidity and mortality from major diseases, improving lives of citizens;
• Health care professionals have access to a screening platform and clinically validated biomarkers for identifying people at risk of disease to facilitate the selection of the most appropriate preventative action;
• Researchers have new biomarkers for prediction and prevention to allow for the development of safer and more effective personalised interventions tailored to the individual’s characteristics;
• Healthcare systems will benefit from reliable evidence to target effective, preventative therapeutic interventions to those citizens who will benefit most from them.

¹ _{Unmet public health needs are needs currently not addressed by healthcare systems for various reasons, for example if no medicines are known to treat a disease. Areas of public health importance are those where the burden of disease is high for patients and society due to the severity of the disease (in terms of mortality, physical and functional impairment, comorbidities, loss of quality of life…) and/or the number of people affected by it. For example, Alzheimer’s disease.}

Scope

As the population of the European Union ages, the rising burden of disease is a major challenge to the sustainability and resilience of healthcare systems. The identification of individuals at risk of developing an illness so that they can receive an appropriate treatment before the disease develops is an important factor to address this problem. However, for many health conditions, we lack full understanding of the underlying mechanisms, including the predisposition to disease and how environmental and genetic factors affect the occurrence of the disease.

Projects funded under this topic should address this challenge by developing an open platform for screening individuals with the aim of identifying people at risk of disease. Applicants should clearly identify a disease(s) of unmet public health need, and specify the initial biomarkers to identify people at risk that will be used within the project (e.g. genetic, metabolic, digital and imaging biomarkers, lifestyle/environmental, family inherited disease, and/or combinations of these) and explain their choices with relevant evidence where possible. By the end of the project, the screening platform should be able to be used for population screening and decision-making including selection of the most appropriate intervention(s) and new technology development.

In particular, for the selected disease(s), the project(s) funded under this topic are expected to:

• Set up a comprehensive interdisciplinary collaboration of the clinical research, industrial, public health, and health technologies communities to develop the screening platform and generate the evidence base for general population screening. This platform should be built to operate in an open-source environment allowing interoperability with applications from different providers, and build on clearly identified existing initiatives where relevant, while aiming at facilitating reusability (for example, a modular structure to enable flexibility and customisation to support new developments). The ethics considerations of operating such a platform must be considered and relevant guidelines for digital biomarker design and development should be followed as appropriate.
• Clinically validate and assess the utility of the screening platform and biomarkers¹ to identify people at risk by designing and implementing a large-scale general population cohort screening study in several representative European countries.
• Design and clinically validate innovative assay technologies for disease risk identification, including digital technologies with data capture/analysis.
• Deliver digital tools for more effective and efficient management and execution of screening programmes and improved disease prevention. Artificial intelligence (AI) tools should be robust and explainable where relevant.
• Publish the relevant methods, standard operating procedures (SOPs), algorithms, standards and guidelines to allow the platform to be used more broadly and for diagnostics and therapies to be developed.
• Develop a plan/roadmap based on solid evidence to facilitate the regulatory qualification of the biomarkers identified and used within the project, and seek engagement with regulators where relevant (e.g. through the EMA Innovation Task Force, scientific advice).
• Develop and optimise relevant clinical practice guidelines through systematic evidence and outcome review, while addressing factors influencing uptake of these biomarkers in clinical practice.
• Raise awareness of disease prevention and provide training and education to relevant healthcare professionals, patients and family members. These training materials should be made available for use after the project ends.

A key objective is to facilitate changing healthcare practice, so applicants will need to demonstrate that their outputs can be taken up by healthcare systems and take steps to facilitate this.

Applicants should also reserve resources to synergise with other relevant initiatives, including other projects funded under this topic.

¹ _{Biomarkers are biological characteristics, which can be molecular, anatomical, physiological, or biochemical. These characteristics can be measured and evaluated objectively. They act as indicators of a normal or a pathogenic biological process. They allow the assessment of the pharmacological response to a therapeutic intervention. A biomarker shows a specific physical trait or a measurable biologically-produced change in the body that is linked to a disease or a particular health condition. A biomarker may be used to assess or detect a specific disease as early as possible (diagnostic biomarker), the risk of developing a disease (susceptibility/risk biomarker), the evolution of a disease (prognostic biomarker) – but it can also predict response to a given treatment including potential toxicity (predictive biomarker).}

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IHI-03-02

Patient generated evidence to improve outcomes, support decision making, and accelerate innovation

Indicative budget: € 6–8 million
Opening: 13 December 2022
Deadline: 15 March 2023

Keywords: patient-reported outcome measures; patient preference information; policy dialogue; awareness raising; patient-reported experience measures; integrated healthcare; m-health; e-health

Expected Outcome

Research and innovation (R&I) actions (projects) to be supported under this topic should aim to deliver results that contribute to all of the following expected outcomes for the use cases selected:

• Decision makers have new methods for the integration of PROMs, PPI, and PREMs and other people-generated information into regulatory and health technology assessment (HTA) evaluation processes for integrated healthcare solutions.
• Patients of all ages have access to novel integrated healthcare solutions¹ that are developed using structured patient input and better respond to their needs and preferences.
• Researchers have new methodological approaches to elicit and integrate patient preferences into the conception, development, and implementation of integrated healthcare solutions¹.
• Researchers have wider access to interoperable, quality patient input and patient-generated data, respecting the FAIR (findable, accessible, interoperable, reusable) principles, facilitating the research and development of integrated healthcare solutions.
• Researchers are provided with new outcomes, outcome measures and the time horizon over which value should be assessed to develop appropriate tools and methods for the collection and analysis of PROMs, PPI, and PREMs.

¹ _{Integrated healthcare solutions are innovative solutions integrating various technologies, coupled with complementary tools and services.}

Scope

The amount of health data generated by citizens themselves is rapidly increasing. Such data includes patient-reported outcome measures (PROMs), patient preference information (PPI), and patient-reported experience measures (PREMs), as well as other digital health data/digital biomarkers. While the potential for these data to be harnessed to improve individual healthcare is enormous, these data are often fragmented among multiple providers, so that neither the citizen, nor the healthcare ecosystem have a comprehensive overview, and therefore it is very challenging to fully use these data to provide reliable evidence for decision-makers, and to improve health outcomes.

Research and innovation (R&I) actions to be supported under this topic will aim to address this challenge by:

• Developing a framework to integrate patient input and patient-generated data for use in decision making (regulatory, health economic evaluation, reimbursement, healthcare programme design, tailored prescription of therapies, and technology development), benefit-risk evaluation and value assessment of integrated healthcare solutions.¹ Applicants should build on existing frameworks where appropriate and appropriately address ethics considerations.
• Implement several use cases to support and demonstrate the use of the framework, focusing on using patient input and patient-generated evidence to address challenges that are not adequately addressed by other initiatives. These use cases should demonstrate the value of using patient input (PROMs, PPI, PREMs) and patient generated data (digital health data/digital biomarkers) along the healthcare continuum, including showcasing improvements to data interoperability, healthcare workflows and processes, disease prevention, and care, including home-based care. These use cases should also act as examples of best practice for future use of the framework.
• Facilitating multi-stakeholder access to patient inputs and patient-generated health data such that actionable harmonised data can be used for quality decision making.
• Comparing/contrasting the properties of the three types of patient input (PROMs, PPI, PREMs), identify differences and opportunities for integrated/complementary use.
• Developing an approach or approaches to integrating PROMs, PPI, and PREMs data into the design of core outcomes sets, end-to-end patient treatment pathways, clinical decision support systems, and treatment guidelines. The core outcome sets used within the project should be made available more widely where possible.

Applicants are expected to seek engagement with regulators where relevant (e.g. through the EMA Innovation Task Force, scientific advice) and consider allocating appropriate resources to explore synergies with other relevant initiatives and projects.

¹ _{Integrated healthcare solutions are innovative solutions integrating various technologies, coupled with complementary tools and services.}

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IHI-03-03

Combining hospital interventional approaches to improve patient outcomes and increase hospital efficiency

Indicative budget: € 6–8 million
Opening: 13 December 2022
Deadline: 15 March 2023

Keywords: fragmentation; innovative interventional approaches; evaluation methodologies; advanced analytics; artificial intelligence

Expected Outcome

Research and innovation (R&I) actions (projects) to be supported under this topic should aim to deliver results that contribute to all of the following expected outcomes:

• Patients will be offered improved, evidence-based, innovative hospital treatment combinations that lead to better outcomes.
• Healthcare professionals will have access to improved clinical decision support systems that will recommend personalised treatments using patient-specific datasets collected in the hospital setting.
• Healthcare systems will have better evidence on cost-effective combinations of interventions and how these combinations can increase hospital efficiency.
• Researchers will have improved information on treatment combinations to facilitate the development of improved interventions.

Scope

Patients admitted to hospital to undergo elective or non-elective procedures typically require recovery and rehabilitation to get back to normal life. New treatment approaches such as minimally invasive surgical approaches, locoregional interventions, novel imaging and diagnostic techniques, clinical decision support systems, and robotics have the potential to reduce complications, facilitate faster recovery, and help increase hospital efficiencies. However, due to limitations in interoperability, reliable evidence and suitable guidelines, these innovative approaches, treatment options and clinical decision support systems are not being optimally combined to provide the best patient care.

Projects funded under this topic should address this challenge by showcasing how existing hospital interventions, treatment approaches and technologies can be optimally combined to improve patient outcomes, enhance patient pathways, generate efficiency gains, reduce hospital staffing challenges, help to lower costs, and decrease societal burden.

In particular, projects should:

• Access and integrate clinical data routinely generated using existing technologies during the patient journey (e.g. medical history profile of patients, diagnosis achieved, for example, by medical imaging and in-vitro diagnostic (IVD) tests, digital information generated during the hospital procedure, vital signs and anaesthesia management, electronic healthcare record systems (EHRs), and drug prescriptions such as analgesics). The interoperability of these data should be addressed as appropriate. Suitable, secure IT infrastructure to support edge and cloud computing in compliance with the general data protection regulation (GDPR) and other data privacy policies at national and local levels should be utilised.
• Train and clinically validate explainable AI algorithms to support the development of training programmes, procedure planning and intraoperative assistance solutions, including clinical decision support systems.
• Demonstrate, via use cases using these data & algorithms, how combinations of and/or synergies between the above-mentioned tools, technologies, and therapeutic approaches can be harnessed to improve patient care. This should include comparing the combination of innovative interventional approaches and clinical decision support systems (CDSS) versus limited or no systematic combination of these innovative interventional approaches and CDSS.
• Implement tools to confirm successful treatment during or after the procedure and monitor therapy response and disease regression.
• Develop and implement new methodologies to assess and demonstrate the added value of combining innovative interventional approaches and clinical decision support systems to all relevant stakeholders.
• Encourage the uptake of the results of the project through a strong communication and outreach plan, including the publication of a gap assessment in order to guide future research in this field.

Applicants are expected to consider allocating appropriate resources to explore synergies with other relevant initiatives and projects including any projects resulting from Horizon Europe Cluster 1 Health topics, and, where relevant, seek engagement with regulators (e.g. through the EMA Innovation Task Force, scientific advice).

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IHI-03-04

Strengthening the European translational research ecosystem for advanced therapy medicinal products (ATMPs) for rare diseases

Indicative budget: € 6–8 million
Opening: 13 December 2022
Deadline: 15 March 2023

Keywords: rare diseases; advanced therapy medicinal products; centres of excellence; clinical networks

Expected Outcome

Research and innovation (R&I) actions to be supported under this topic must work towards results that contribute to all the following expected outcomes.

• A sustainable network of centres of excellence, that should:
  • advance the most promising, impactful, translatable, quality-controlled technologies that address the bottlenecks in the development of ATMPs and other related innovative therapeutic modalities such as the use of messenger RNA (mRNA), or nucleic acids and nanoparticle (NPs) delivery for gene editing;
  • make these technologies accessible to all actors involved in the development of ATMPs and other related innovative therapeutic modalities, including the research community, academia, clinics, small to medium-sized enterprises (SMEs), healthcare professionals, biotech, medical technology and pharmaceutical companies, and patients;
  • share information, processes and methods, and build capacity in science and technology, and regulatory awareness of ATMPs, including the ability to assist industrial and academic developers of ATMPs in their translational research.
• Consensus reached on quality standards (e.g., of analytical methods) and translation process by the ATMP community at large that support the timely and robust development of ATMPs and other related innovative therapeutic modalities.
• Strengthened interactions with regulators to enable a more streamlined and transparent regulatory pathway that will optimise and speed up the development and delivery of ATMPs and other innovative therapeutic modalities for rare diseases for the benefit of patients, carers, healthcare systems and society.
• Improved technologies/processes, analytic tools, methods including non-clinical methods, and assays useful for the development of ATMPs and other related innovative therapeutic modalities, beyond those targeting rare and ultra-rare diseases.

Scope

There are over 7000 rare diseases resulting in 30 million patients¹ in Europe with a rare disease. Globally more than 300 million patients² are affected. In Europe, less than 10 % of rare disease patients receive treatment and only 1 % are managed using an approved treatment. ATMPs such as gene and cell therapies and other related innovative therapeutic modalities, are very promising to treat patients with rare diseases, especially ultra-rare diseases. However, ATMPs rely on complex technologies where the development process is hampered by a lack of standardisation, scalability and reproducibility.

The overall aim of this topic is to optimise and streamline the future development of ATMPs and other related innovative therapeutic modalities for rare diseases by strengthening the ecosystem that facilitates the transition of early pre-clinical proof-of-concept research to clinical development. This topic focuses on the scientific, technological and regulatory barriers that are limiting translational research into rapid and cost-effective development of ATMPs and other related innovative therapeutic modalities for rare diseases.

To fulfil this aim, the proposals should:

• Establish a network of scientific and technical centres of excellence (new and/or existing laboratories/institutions) complementing each other to enable translational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of genetically defined diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controlled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks, including the ERNs on rare diseases.
• Develop tools and methods and define key characteristics of ATMPs, and quality standards that are critical to later stages of development of ATMPs and other related innovative therapeutic modalities, in particular those targeting rare diseases with no approved treatment option. Relevant therapeutic modalities must include appropriate vector systems and innovative modalities such as messenger RNA (mRNA) and nanoparticles (NPs) for therapeutics. Technology areas of interest could include targeted delivery (e.g. methods to target distribution), stability (e.g. methods to increase the stability of RNA), transgene expression, advanced redosing technology approaches/reduced immunogenicity of gene delivery platforms, and other underlying biology relevant to the specific therapeutic modality enabling accelerated translation to clinical development and manufacturing.
• Develop and support the uptake of standardised analytical assays, methods and technological platforms, other non-clinical methods and design strategies as well as translation processes for:
  • reducing the timeframe and costs and improving the future development of ATMPs and other related innovative therapeutic modalities and/or;
  • optimising manufacturing processes to maintain product quality while ensuring broad accessibility of critical manufacturing materials and demonstrating the economy of scale for ATMPs or other related innovative therapeutic modalities.
• Demonstrate the translatability, scalability, and robustness of technologies suitable for the development of subsequent ATMPs and other related innovative therapeutic modalities. This may include process development, mRNA and NPs scale-up and stability, vector production, increasing the throughput of the systematic assessment of the biological and mechanistic features and product characterisation, and ensuring broad accessibility of critical manufacturing materials such as cell lines and producer plasmids.
• Assess the methods and technological platforms developed for their translational and regulatory validity/utility. Define a regulatory pathway to support the fit-for-purpose development of ATMPs, taking into account an evolving regulatory environment and the interplay between all applicable legislation. Ensure early engagement with the regulators so that the methods and data generated support regulatory needs.
• Validate the performance of the methods and technologies developed and demonstrate their higher performance in comparison to existing methods for addressing the bottlenecks in the development and manufacturing cycles of ATMPs and other related innovative therapeutic modalities. In addition, test the functionality of the centres of excellence and demonstrate their capability and performance to support translational research through use cases.To achieve this, the submitted proposals must plan for an open expression of interest / call process to invite third parties, external to the initially established consortium, to submit use cases at least twice during the lifetime of the project. These use cases must:
  • showcase the utility and validity of the methods and technologies developed and verify that they are fit for purpose in the context of the scientific, technological or regulatory challenges; and
  • measure and help adjust the capability and performance of centres and networks of excellence in assisting industrial and academic developers of ATMPs in their translational research.

  For the use cases, clinical validation of technological solutions developed would be in the scope of this topic (within the framework of the above objectives). While conducting full randomised controlled trials are out of scope for this topic, other forms of clinical studies are in scope under the use cases, which may include pilot clinical studies, observational studies, real world data studies etc., depending on the needs of proponents of the use cases.

• Contribute to strengthening the European rare disease ecosystem by engaging all relevant stakeholders, especially patients and patients’ representatives for rare diseases, carers, clinicians, and regulators.
• Define relevant metrics and measure the use of centres of excellence by relevant stakeholders for the development of their assets or novel technological solutions/therapies.
• Define a plan for sustainability beyond the lifetime of the project, including consideration for potential expansion to additional promising technological areas.

Applicant consortia should take stock of the state-of-the-art methods and technologies delivered by other EU and global initiatives on rare diseases (e.g. the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium, the Innovative Medicines Initiative (IMI) project ARDAT, the European Joint Programme on Rare Diseases and the future European partnership on rare diseases, or other EU-funded consortia). Proposals should plan for synergies and collaborations to ensure complementarity while avoiding duplication.

¹ _{http://www.eurordis.org/information-support/what-is-a-rare-disease/}

² _{http://www.nature.com/articles/s41431-019-0508-0}

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IHI-03-05

Digital health technologies for the prevention and personalised management of mental disorders and their long-term health consequences

Indicative budget: € 6–8 million
Opening: 13 December 2022
Deadline: 15 March 2023

Keywords: digital health technologies; mental healthcare; early prevention; precise diagnosis; pathway management; European Health Data Space; long-term impact

Expected Outcome

R&I actions (projects) to be supported under this topic must contribute to all of the following outcomes:

• Robust evidence on the feasibility, acceptability, adherence, and personal satisfaction with digital health technologies (DHT) in people with mental disorders. People with mental disorders and their families/caregivers should be included in evidence generation. This includes pathways to maximise motivation and engagement with DHT of all relevant end-users and healthcare actors. This includes patient-centric selection of potential application features, measurement technologies and digital endpoints. Proper attention should be given to the issues of vulnerability, stigma and difficulties related to limited digital/eHealth literacy. Consideration should be given to ethical, cultural, gender and age-specific (e.g. adolescents’) needs and preferences to ensure continued use of the DHT.
• A flexible, interoperable, and reusable digital platform that can be used across numerous conditions and scenarios (various mental disorders, comorbidities, long-term health consequences and other disease areas) to collect, analyse and integrate diverse multimodal clinical and patient data, including patient reported outcome measures (PROMs) and patient reported experience measures (PREMs), with an emphasis on those generated by DHT. Variability across countries should be addressed, as digital infrastructures and the availability of digital tools may differ. Mapping of the specific links between digital infrastructures and types of digital health technology (e.g. concepts, data types, standards, technological approaches) should be included. Consideration must be given to ethical, social, and legal aspects and to the FAIR (findable, accessible, interoperable, reusable) principles.
• Effective and agreed guidelines for the development and implementation of DHT in clinical research and as a part of everyday health and care, enabling the development of more patient-centric treatments, optimised health and care interventions and better disease prevention. Evidence from quantitative studies on potential favourable/unfavourable effects of the technologies on care, and on their impact on changing clinical research and clinical trials should be included. Relevant organisational and work processes, policy and regulatory aspects should be addressed to foster the sustained integration of DHT in real world practice.
• Robust knowledge for better understanding of mental disorders, their change over time and how all this relates to clinical outcomes including the remission, relapse, and recurrence of the conditions, long-term health conditions and mortality and/or surrogate outcome measures when relevant. Socioeconomic outcomes and family/caregiver burden should be addressed. Better insights into other aspects like patient adherence to therapy and adverse drug reactions should be gained.
• A robust body of data to enable the development of digital tools that optimise the engagement of people with mental disorders, caregivers and other relevant actors (healthcare professionals, social workers etc.) adapted to the needs of the patient population and age-specific needs, tackling the issues of stigma, vulnerability, lack of treatment seeking and overall poor adherence to treatment (including lifestyle related). Consideration should be given to providing intuitive equipment and user interfaces and easy troubleshooting.
• Enhanced and more reliable tools and methods (e.g. analytical tools and algorithms) able to provide (near) real time feedback on the DHT, including on the usability, efficacy/effectiveness, and long-term safety. Together, these enable healthcare professionals and providers to make more inclusive and efficient patient-centred decisions in collaboration with the people with mental disorders and their families.
• Robust evidence of how DHT may influence the treatment or behaviour of people with mental disorders. The inclusion of schools/social workers/psychologists in evidence generation should be considered where relevant.

Scope

Mental health disorders represent an area of severe unmet public health need. This has been further negatively impacted by the COVID-19 pandemic, with a substantial increase in the number and severity of people affected for example by anxiety and depression¹, which places substantial pressures on already strained mental health care systems. People with mental disorders have a reduced life expectancy compared to the general population, and this is linked to a greater risk of developing a range of chronic physical conditions². The long-standing separation of psychiatry from other branches of medicine and the lack of specific training on this issue further contribute to the poor attention dedicated to management of comorbidities of mental health disorders.

Digital health technologies (DHT) applied via electronic devices such as wearable sensors, implanted equipment, and handheld instruments and smartphones have already shown significant promise for the prevention and disease management of chronic conditions (e.g. cardiovascular disease, diabetes, obesity). DHT, by making it possible to virtually perform medical activities that have traditionally been conducted in person, also have the potential to decrease the pressure on healthcare systems and their personnel. Thus, DHT might have the potential to address some of the challenges in the prevention, prediction, monitoring and personalised management of mental disorders and their long-term health consequences, as well as to tackle some of the organisational issues in providing mental health care³.

The scope of this topic is to investigate how DHT might positively impact the healthcare pathway for people with mental disorders.

Applicants should demonstrate how DHT may enable:

• better prevention and prediction of disorder onset or relapse;
• better disease management;
• tackling comorbidities;
• addressing long-term health consequences (such as cardiovascular disease or diabetes).

The choice of the specific mental disorder should be justified based on unmet public health need, its impact on quality of life of people with mental disorders and their families/caregivers as well as the feasibility and preliminary evidence available on the use and value of DHT.

To contribute to breaking the silos between psychiatry and other medical branches and better address the impact of co-morbidities in people with mental disorders, applicants should consider relevant co-morbidity/ies where DHT data, learnings and technologies are already available and can be further developed/applied to mental disorders. Co-morbidities can significantly exacerbate mental health disorders, impacting quality of life and the development of long-term health consequences The choice of comorbidy/ies must therefore be justified accordingly.

Ways of decreasing the burden on caregivers and families should be considered, and applicants should actively engage these actors as well as the people with mental disorders in addressing critical issues and research questions, including about (sustained) engagement with DHT⁴. Consortia should propose ways to foster the future integration of digital and clinical mental healthcare, as well as how DHT might enhance the outcomes of interventions by social and healthcare professionals while decreasing the burden on the healthcare system. Applicants should adequately describe how they plan to measure such burden.

Resources and learnings from previous initiatives at European and national level (Innovative Medicines Initiative funded⁵ among others) should be taken into consideration.

Applicants should aim to deliver robust evidence on how DHT may be:

• made easy to adopt and use in a sustained way for both people with mental disorders, their families/caregivers and health and care providers;
• effectively incorporated into clinical research and in clinician workflows.

Early engagement with regulators should be sought to ensure the future acceptance and usability of the results for example through scientific advice, qualification advice or qualification opinion.

Applicants are expected to implement activities to achieve all expected outcomes.

Applicants are expected to consider allocating appropriate resources to explore synergies with other relevant initiatives and projects.

¹ _{https://www.who.int/news/item/02-03-2022-covid-19-pandemic-triggers-25-increase-in-prevalence-of-anxiety-and-depression-worldwide}

² _{https://annals-general-psychiatry.biomedcentral.com/articles/10.1186/s12991-021-00374-y; https://www.nature.com/articles/s41569-020-00463-7}

³ _{https://www.frontiersin.org/articles/10.3389/fdgth.2021.764079/full}

_{4 https://www.imi.europa.eu/projects-results/project-factsheets?keywords=digital+technology&status=All&call=All&programmes=All&disease_areas=All&products=All&tools=All;}

_{5 https://www.imi.europa.eu/projects-results/project-factsheets?keywords=radar+cns&status=All&call=All&programmes=All&disease_areas=All&products=All&tools=All}

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IHI-04-01

Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical drug safety assessment

Indicative budget: In-kind contributions
Opening: TBD
Deadline: TBD

Keywords: non-human primates; new research pathways;  non-invasive digital technologies; non-animal models; knowledge sharing

Expected Outcome

• Obtain and share biological knowledge of minipigs, thereby facilitating the development of innovative solutions by improving the translational understanding between minipigs versus NHPs and humans, including further understanding of the minipig immune system, with the overall aim to replace, reduce and refine the use of animals in drug safety assessment;
• A regulatory pathway for drug safety assessment of biologicals and other novel therapeutic modalities in minipigs with the potential to impact regulatory strategies;
• Publicly available databases and software for physiologic, genomic, transcriptomic, metabolomic, proteomic and epigenetic minipig data to understand underlying mechanisms of disease/toxicities and find new mode of actions for pharmaceutical intervention;
• Characterized and validated genetically modified minipig models:
  • Genetically modified minipig models based on the CRISPR/CAS inducible gene-editing technology;
  • Minipigs with “humanized” immune system components and effectors for biologicals’ testing;
  • Small–sized micropig for efficacy/safety assessment to facilitate compound availability in pharmaceutical R&D;
• Assessment of the utility of the minipig as a relevant toxicology species for immunosafety testing using drugs, which have been tested preclinically and clinically. Assisting and synergizing the already existing translational and regulatory efforts related to immunological safety evaluation. Developing validated antibodies and in vitro immunoassays to characterize the immune system and assess immuno-safety of drugs in minipigs;
• Minipig-specific technology for automated study data: validated medical devices, biosensors, algorithms, software, and digital animal housing. Machine learning and Artificial Intelligence (AI)-based tools to monitor abnormalities in behaviour and physiological systems in undisturbed animals.

To ensure long term sustainability, all the obtained interdisciplinary science-based knowledge generated in this proposal will be shared, integrated, digitalised, and published in peer-reviewed journals encouraging industry and academia to develop innovative medical science solutions and technologies, such as scientifically and ethically sound animal models, assays, biomarkers, monitoring devices, biosensors for normal physiological behaviour and algorithms. Based on the close collaboration with regulatory bodies, the generated knowledge in this proposal is further expected to impact regulatory guideline strategies. All outputs will require long term sustainability and maintenance to fulfil the scope of the proposal.

Scope

Challenges:

• Increasing need to find alternatives to testing in NHPs in line with EU legislation;
• Lack of knowledge about minipigs in safety assessment to allow de-selection of NHP as second nonrodent species across diverse drug modalities with strong scientific confidence;
• Almost no precedence in minipig use for safety testing of biologicals and novel therapeutic modalities [e.g., oligonucleotides, small interfering RNAs (SiRNAs), crystallizable fragments (Fcs), antigen-binding fragments (Fabs), single-chain variable fragments (scFvs), monoclonal antibodies (mAbs), vaccines, gene-editing and cell-based therapies];
• Lack of public minipig reference “omics” with good quality annotation: Full genome sequencing, in parallel with baseline transcriptomics, proteomics, metabolomics and epigenetic information;
• Lack of “humanized” and genetically modified models available for drug efficacy/safety testing, including genetically modified smaller micropigs to address cases of limited substance supply;
• Significant knowledge gap on the minipig immune system and reduced number of laboratory tools and reagents when compared to other toxicology species (rodent and non-rodent);
• Lack of widespread use of biosensors, medical devices, “intelligent” animal housing for automated data collection and analysis in minipig studies.

Objectives:

The overall objective of this proposal is to characterize the minipig for use in R&D of medical technology, device, and pharmaceutical development. The knowledge generated in this proposal may facilitate innovative health solutions, improve disease understanding and human predictions. The goal is to advance biomedical R&D by generating background scientific data to evaluate if the minipigs could be a viable and feasible alternative to NHP in key therapeutic areas, with a special focus on translatability from minipigs to humans.

Key activities:

• Safety assessment and regulatory aspects of novel therapeutic modalities: Compile and publish historical data in minipig biomedical R&D;
• Evaluate the translatability of minipigs in human risk assessment following treatment with biologicals and novel therapeutic modalities and discuss future perspectives of the minipigs with regulatory agencies;
• Minipigs multi-omics: Generate omics reference data (genomics, transcriptomics, proteomics, metabolomics, and epigenetic information) to enable translational research in minipigs;
• Genetically modified pig models including the micro-pig: Characterise and validate humanized and genetically modified minipig models, including the micropig to generate translatable animal models in drug safety assessment.
• iPig: Digital technologies, clinical data collection and AI: Create, validate, qualify, and benchmark digital solutions that can objectively measure clinically relevant and functional biomarkers in minipigs for use in preclinical toxicity studies in line with the regulatory agencies’ requirements;
• Minipig immune system: validate reagents, assays, and biomarkers for immunologic investigations: Conduct investigative studies in minipigs to support their translational significance in immuno-safety assessments and validate reagents/assays;
• Project management: Compile, digitalise, publish existing and newly produced data.

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IHI-04-02

Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare

Indicative budget: In-kind contributions
Opening: TBD
Deadline: TBD

Keywords: obesity, biological pathways and pre-obesity markers, environmental, socio-economic and lifestyle factors, prevention, evidence-based guidelines, recommendations

Expected Outcome

The results of the project generated by this topic will enable innovations in healthcare delivery and research by generating the infrastructure and logistics for blood collection at home, that is simple, minimally invasive, less painful, convenient, and feasible.

Importantly, the project will also set the stage to answer research questions by creating an unprecedented data set that will enable multiple secondary research options for years to come. Notably:

• It will create insights into the public acceptability for microsampling home: are patients comfortable with a new kind of medical technology? What training is necessary?
• Are we able to advance the transition of care from the hospital to the home? Does the care quality improve?
• How do we utilize the higher frequency of data, including its integration with electronic medical records and using advanced analytics methodology?
• Do doctor’s practices and decisions change with the increased frequency of biomarker data, and does it lead to better outcomes for the patient?

While integrating existing components for microsample collection and central lab analysis, quality standards for the new infrastructure and logistics will be rigorously and transparently validated and established in Europe and harmonised with parallel ongoing efforts in the USA. This will be undertaken in ways that are acceptable for patients and their caregivers, health care professionals, regulatory agencies, policy makers, Health Technology Assessment (HTA) experts, payers, and advocacy groups.

Scope

The overall aim of the project generated from this topic is to create and validate the infrastructure and logistics for blood collection by the patient and/or caregiver at home as a healthcare tool and an alternative to the current gold standard venous blood for routine clinical assays. This project will employ only commercially available CE-marked microsampling devices, according to their intended use.  Development of new devices for blood sampling or of new clinical assays / analytes is not the focus of this project, and no new clinical assays will be evaluated. Similarly, given their current maturity, home sample analysis is out of scope.

Training materials, customised for patients and caregivers as well as for medical personnel will be developed, ensuring the acceptability of the new approach to these groups. Interactions with regulatory authorities, the European Medicines Agency (EMA), local European agencies as well as the USA Food and Drug Administration (FDA) will be sought to advance regulatory acceptability of the logistics model and harmonization across the EU, the UK and USA. Further, key stakeholders (e.g. policy makers, HTA experts, payers, patient advocacy groups) will be encouraged to implement the infrastructure and logistics throughout Europe. Lastly, the best ways to integrate, transmit, and analyse (including AI) the generated data will be explored. Results will be shared broadly through peer-reviewed publications or other mechanisms.

To be noted – home blood microsampling has been used in geographically restricted pilot projects. With the project generated from this topic , it is expected to generalise them, and leverage the learnings from the pilot projects, to enable broad adoption. Importantly, it is known that patients greatly appreciated this experience compared to the traditional blood sampling methods currently in use.

Applicants should in their proposal entail the following:

1. Demonstration of concordance between patient-centric microsampling techniques and venipuncture

This requires delivery of a framework across Europe for establishing concordance between capillary blood as collected by microsampling devices outside of traditional collection setting by the patient and/or caregiver, versus the gold standard venous blood, for routine clinical assays.

• To generate an umbrella / master protocol that is acceptable for regulatory authorities in Europe and UK and can be easily adopted for future applications (e.g. in additional patient populations, countries, by any vendor or organization). The umbrella / master protocol must include:
  • Sites in at least 3 EU member states, and may include additional sites in third countries associated to Horizon Europe or other European countries (e.g. UK); at least one of the countries must be in Central or Eastern Europe;
  • At least two different types (e.g., finger stick, upper arm capillary) of commercially available CE-marked microsampling devices;
  • Routine clinical assays: i.e., blood chemistry, liver and lipid panels;
  • Collection of at least 50% of microsamples by the caretaker or patient;
  • Collection of least 50% of microsamples at home, and may include collections in other locations (e.g. hospitals, general practitioners, specialists’ offices) for concordance testing and establishing microsampling of capillary blood versus venous blood for routine assays;

• To design, adapt, and translate patient-facing materials, obtain ethics board approvals, recruit healthy human volunteers and expand to a patient population which should be agreed upon in a project committee, collect biological samples and conduct bioanalysis according to the study protocol;
• To investigate potential errors related to the mishandling of samples and design ways to mitigate them, as well as the potentially harmful downstream effects for the individual;
• To conduct concordance analyses according to existing regulatory guidance for routine clinical assays, and define sample quality criteria (if applicable).

2. Validation of the logistics of sample collection and shipping, standardising central lab analysis.

This requires identification of an optimum workflow for device ordering, fulfilment, shipping, at-home collection and return to central labs and a seamless integration of microsampling into current central lab processes; accessioning, analysis and reporting.

• To select at least two different types of CE-marked microsampling devices, and identify and audit device vendors with ordering (portal) and fulfilment capabilities; to work with device vendors on ordering devices;
• To define appropriate shippers/processing/temperature based on the devices and assay requirements, and confirm requisition requirements;
• To identify strategic partners in terms of Logistical expertise, e.g. global couriers;
• To identify countries to test devices in and confirm regulatory requirements for self-collections or collections by caretaker and shipping of devices;
• To define needed support for use of devices and train participants on devices; to identify telehealth partners e.g. for identification verification;
• To identify the best ways to integrate the new data with existing electronic medical records and medical decision frameworks;
• To investigate the “green dimension” of logistics: microsampling has the potential to reduce the green footprint of office visits and transportation required (fuel, costs, carbon emissions);
• To confirm accessioning process needed, reporting requirements, and data management model.

3. Education and Medical & Patient Acceptability

• To deliver training materials for patients, caregivers and clinical trial sites, ensuring smooth behindthe-scenes shipment logistics and support;
• To develop guidelines for compiling training materials to meet expectations from different training recipients, such as clinical sites, patients, caregivers, telehealth and home health providers, leveraging previous feedback collected from users (patients, caregivers, principal investigators (PIs) and medical personnel), including to develop training by telehealth;
• To develop a plan to collect patient, caregiver and medical personnel (site staff, PIs, trial coordinator) experience and feedback:
  • To develop a well-designed questionnaire that will be used either electronically or in paper format, develop tool(s) to collect feedback and store the information, pilot the use, refine the questionnaire and data base as needed;
  • To implement the questionnaire to collect feedback from different groups (patients and caregivers, medical personnel, regulators, device manufactures);
  • To maintain a database of information collected and perform data analysis to obtain patient acceptability scores.
• To publish survey results to validate the training and feedback with other patient advocacy groups.

4. Regulatory acceptability and implementation into clinical practice in the EU, UK and USA

• To prepare an overview of the regulatory landscape of microsampling at home per country in the EU, third countries associated to Horizon Europe, and other European countries (e.g. UK), and to conduct an in-depth exploration in those countries that might be suitable for the “Microsampling logistics modelling;”
• To establish early and continuous dialogue with the European Medicine Agency (EMA) / Innovation Task Force, in addition to local regulatory agencies of the EU, the USA-FDA and other relevant authorities, e.g. the UK Medicines and Healthcare products Regulatory Agency (UKMHRA):
  • To assess acceptability with regulators and seek (informal) prospective input on the umbrella / master protocol, choice of countries and approach to validate the logistics.
  • To discuss the best strategy/timing for qualification and/or integration of project outputs into regulatory practices, prepare relevant documents (e.g. briefing books, EMA guidance document) to share project results, request scientific and qualification advice, and seek a harmonization with the USA-FDA and other authorities, e.g. UK-MHRA.
• To establish early and continuo

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HORIZON-JU-IHI-2022-02-01

Cardiovascular diseases – improved prediction, prevention, diagnosis, and monitoring

Indicative budget: € 22 million
Opening: 28 June 2022
Deadlines: 20 September 2022 (First Stage), 28 February 2023 (Second Stage)

Keywords: cardiovascular diseases; prediction; prevention; diagnosis; monitoring; harmonised methodology; access and integration of heterogeneous health data

Expected Outcome

The results of the selected project will provide the basis for better primary and secondary prevention of CVD. The goal is to identify existing comprehensive CVD and heart failure (HF) patient datasets (with contextual parameters e.g., behavioural, socioeconomic, gender, ethnicity) and integrate them with data from diagnostic tools (e.g. wearables, imaging devices, bio samples / biopsies) and routine clinical practice. This will provide the basis for independently validated prediction models for improving the stratification of patients, and reveal insights to achieve earlier intervention. Additionally, the project will leverage developed algorithms to define and validate care pathways that tailor therapy towards individual patient needs and compare it to the “one-size-fits-all” approach.

This project is expected to achieve all of the following outcomes:

• Identification of relevant data sets, for instance derived from classical diagnostic screening; in-vitro diagnostics; ‘multi-omic’ platforms (comprising genomic, transcriptomic, proteomic and multimodality imaging data, most preferably with multiple timepoint assessments to ascertain the directionality and dynamics of relevant changes); continuous glucose monitoring (CGM) data, continuous electrocardiogram (ECG) data from wearables. In addition HF and activity data, wearable devices, digital health applications and routine clinical practice;
• Leverage data in currently available federated databases with ‘open access’ generated during, for example, IMI1/IMI2 projects in compliance with GDPR (General Data Protection Regulation), such as results/data/biomarkers/electronic health records provided by project participants, adding to the knowledge base;
• Demonstration of the utility of biomarker combinations including data from different modalities e.g., wearables, smart (acute or chronic) care setting devices, imaging/screening for the diseases and comorbidities;
• Based on existing biomarker combinations, determination of whether new biomarkers are needed for detecting patients at risk;
• Developed and/or evaluated artificial intelligence (AI) models that, using data from various sources, can identify patient subgroups who require and respond differently to the prevention and/or treatment of atherosclerotic cardiovascular disease (ASCVD) and HF in clinical practice;
• Identification of previously undiagnosed subgroups of ASCVD and HF patients, for instance people with insulin resistance, diabetes, and obesity, into clinically meaningful subgroups;
• Documentation and analysis of patient preferences regarding information, diagnosis and treatment of CVD, as well as requirements and preferences of individuals to share their data;
• Integration of patient data (e.g. via a federated database concept) to enable a holistic overview of specific patient groups to enable more effective and efficient disease management and execution of screening programmes and individual treatment tailoring;
• Inclusion of validated patient reported outcome and experience measure (PROMs and PREMs) data including biophysical, mental and psychosocial parameters with the aim of using it in a clinical setting. This may include, but is not limited to, measures on quality of life, sleep quality, physical activity, emotional stress, satisfaction with treatment, healthcare service experience;
• Leveraging developed algorithms/decision trees to define and validate care pathways that tailor therapy towards individual patient needs and compare them to the “one-size-fits-all” approach;
• Sustainability of relevant results and data repositories;
• Identification of incentives that reward positive health behaviour and motivate consistent and continuous data generation especially when health status has changed;
• Utilisation of the knowledge gained from the project to facilitate and guide better prevention, considering the patient perspective;
• Data collection in the patient population with type 1 diabetes that historically has been excluded from clinical trials. Identifying the highest-risk individuals (in the paediatric, adolescent and adult populations, among others) to aim for more intensive contemporary CVD risk lowering agents (such as glucose, lipid and blood pressure lowering), and other, ideally personalised, cardioprotective adjunct therapies could help reduce the burden of CVD and contribute to improving outcomes in type 1 diabetes;
• Data collection in patient populations with other (genetically defined) predispositions to CVD and HF, that historically have been excluded from clinical trials. Identifying the highest-risk individuals could contribute to improving the outcomes in people with obesity, type 2 diabetes or (genetic) predisposition to CVD/HF.

Scope

The overall aim of the project is to provide tools for the earlier diagnosis of atherosclerosis and heart failure as well as earlier identification of patients at risk. This includes biomarker or predictive algorithms to assess changes in risk and stratify patients according to individual responses to therapeutic intervention. Currently, patient data from various sources such as devices, intake forms, and diagnostic and exploratory tests are not integrated or monitored to give a complete understanding of the patient’s disease state. Integration of these data sets, e.g. by a federated database, and its accessibility to healthcare providers and researchers will provide better understanding to help detect, monitor, and treat ASCVD and HF. The selected project should clearly outline their approach for data capture, storage and sharing, for instance data federation, or an open, centralised database architecture. The proposed data management strategy should be sustainable, seek synergies with other relevant projects, and align with the FAIR principles1. To fulfil this aim, the selected project should:

• Increase our understanding of the initial hallmarks of disease, which will allow for a better identification of individuals at risk for ASCVD and HF at a young age, and the creation of a clinical risk profile based on a multi-omic approach (e.g. genetic markers, transcriptomics, proteomics, and in depth multimodality imaging data) in adolescents who have either genetic and/or enrichment of specific endpoint associated risk factors (obesity, chronic kidney disease, type 1 diabetes, type 2 diabetes, genetic preponderance for HF and increased atherosclerosis);
• Generate and validate a risk model better than currently used risk engines such as SCORE, by evaluating whether and to which extent risk factors identified in large prospective CVD primary prevention cohorts are predictive in a secondary prevention setting. The data from surrogate markers such as imaging, electronic health records (EHR), and predictive markers (plasma based multi- omics), as well as data from wearables, will generate a more refined risk engine;
• Outline the extent to which social, ethical, and regulatory implications can be considered and quantified in the new risk models and gauge the potential additive value of data generated by wearable devices in current healthcare systems. Outline the extent to which regional and legal issues have an impact, and what models and methodologies can be used to examine this. Moreover, as the risk-benefit of wearable derived data will be ascertained in individuals who are likely to be frontrunners in the adoption (i.e. people with type 1 diabetes and people with a (genetic) risk for premature atherosclerosis and/or HF), the project should include behavioural elements to be analysed to provide suggestions to increase adoption in other populations;
• Model short- and long-term economic and public health morbidity and mortality benefit/risk assessments of therapeutic intervention in people at risk with the new risk models to prevent or delay onset of CVDs;
• Develop a decision tool that will allow a physician to select the intervention to best address ASCVD and HF in an individual patient. The tool will provide a risk-benefit profile, helping the physician and the patient in a decision-making process, integrating also patient reported outcome and experience measure (PROMs and PREMs) data;
• Explore possibilities for novel methods of clinical development and trial execution. Based on learnings about risk prediction and pathophysiological modelling, novel surrogate endpoints may be considered for a risk-based cardiovascular outcome trial approach. The project generated from this topic could provide an exploratory and interactive platform to discuss the validity of novel methods of evidence generation, such as the use of data from wearable devices. The project should pave the way to transform the rather static phase 3 clinical trial approach into a more agile (more inclusive/enriched patient population, faster, cost-effective etc.) and sustainable part of clinical development. Specifically, the project should engage in the Regulatory Science Research Needs initiative, launched by the European Medicines Agency (EMA), assessing the utility of real-world healthcare data to improve the quality of randomised controlled trial simulations (H2.3.3). During the COVID-19 pandemic, the world has experienced a transition to virtual and remote care as more and more patients connect with their health care teams online. This presents an enormous opportunity and benefits for patients. A pathway forward could be to through use of real-world evidence (RWE) data to address sex, ethnicity and race disparities in cardiovascular outcome trials and better promote CV management.

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