Upcoming and open funding calls

We're continuously updating this page with calls relevant to biomedical imaging

Below are the full call texts for open and forthcoming calls relevant to biomedical imaging. This includes information on the budget and prospective estimates on how many projects will be funded. You can scroll down, or use the quick menu on the right side of the screen to navigate.

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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HORIZON-JU-IHI-2022-01-01

An innovative decision-support system for improved care pathways for patients with neurodegenerative diseases and comorbidities

Indicative budget: € 135 million
Opening: 28 June 2022
Deadline: 20 September 2022

Keywords: decision-support system; neurodegenerative diseases and comorbidities; next-generation imaging; image-guided diagnosis and therapy for cancer; personalised oncology; access and integration of heterogeneous health data

Expected Outcome

R&I actions to be supported under this topic shall contribute to the following outcomes:

  • A (sustainable) re-usable, interoperable, easily adaptable, and scalable digital platform, capable of translating a heterogeneous and fragmented set of complex measurable and analysable health data elements into a clinical-decision-support system that can guide patients to better health and quality of life. Initially designed for patients with neurodegenerative diseases and comorbidities, the platform’s easy adaptability ensures its re-use in other health areas for the benefit of healthcare professionals, patients, families, and carers, thereby promoting its wider use;
  • A sustainable framework for collaboration across specialities and all relevant stakeholders to foster social innovation to decrease the burden on patients, families, and carers and to develop models to incentivise/maintain collaboration and ensure feasibility of future implementation;
  • Effective and agreed standards and guidelines that support both data collection and all operational features of the digital platform enabling health technology developers to create efficient clinical decision support systems for a more patient-centric and optimised delivery of healthcare interventions. Healthcare professionals/providers use these solutions leading to improvements in the healthcare pathways;
  • Enhanced, and more reliable tools and methods (e.g., analytical tools and algorithms) able to provide (near) real time feedback on health interventions, including on the usability, efficacy/effectiveness, and the long-term safety of health technologies. Together, these enable healthcare professionals and providers to make more inclusive and efficient patient-centred decisions that, additionally, can aid the development of predictive simulation tools and models;
  • Enhanced clinical interpretation of multi-modal, multi-parametric data including socio-economical, which influence variations in the status of the patient with neurodegenerative disease and the required levels of care. This will be benefitting the patients, as a more person-centric treatment and care, and the healthcare providers as optimised allocation of resources, and prediction of how patients’ needs will change due to their co-morbid condition or other precipitating medical factors.

Scope

Neurodegenerative disorders represent a high societal burden impacting patients, their families, and public healthcare systems. Patients with a neurodegenerative disorder frequently display at least one comorbidity, which together with the observed polypharmacy creates a highly complex system that needs better understanding to optimise current care pathways. Recent developments give grounds for cautious optimism that a disease-modifying therapy is on the horizon. However, the high disease prevalence, and the complex evaluation process when such a therapy becomes available, will create challenges for already over-burdened healthcare systems. This will increase the demand for and importance of diagnostic and digital solutions that can drive the related clinical pathways and optimise and personalise care delivery.

The primary objective of this topic is to develop a decision-support system to enhance medical decisions with targeted clinical knowledge, patient information, and other health information for a more holistic (better integrating diagnosis, treatment and care and breaking silos across specialities) approach to managing and treating patients with a neurodegenerative disease and a comorbid condition, addressing the needs of today, while creating preparedness for a future paradigm-shift in treatment.

In their proposal, applicants should formulate how to best achieve all the outcomes/outputs of this topic, also describing the expected actual improvement in care and treatment outcomes and reflecting on aspects of implementation into routine care and sustainability, that are barriers to developing and distributing/delivering innovations. This should be preceded by a key stakeholder mapping to grasp the relevant players within this ecosystem and build and leverage as much as possible upon already available resources and learnings.

Proposals should address a patient population with a neurodegenerative disease where there is evidence of the importance of comorbidities in their healthcare pathways and on patient quality of life. The choice of the comorbidity should consider the burden for patients, carers and families, and the availability of medical technology-generated data. Cancer is out of scope.

Applicants should develop a (sustainable) re-usable, interoperable, and scalable digital platform, to safely and efficiently collect, curate, store, share, access, integrate and analyse multimodal longitudinal, dynamic health data generated within and outside the healthcare setting.

This will require breaking existing data silos across different medical specialities to allow the dynamic flow of information on the concomitant conditions and their interplay to improve the selection of the best possible care pathways, and patient adherence.

Data may include medical/laboratory data, automatically collected data, omics data, medical device data, treatment modality/intervention-type data, real-world evidence, including medical condition and lifestyle-related data collected via e-health solutions, smart devices, wearables, medical grade sensors and other patient self-reported data. Data on contextual information, for example on the socioeconomic environment as well as professional and informal caregivers (like availability, roles, interprofessional cooperation, interaction with the patient/client), the setting and organisation of care, staffing, and payment models, should be considered to enrich the dataset informing decision, as well as data from patient registries. Current European activities on digital health and care should be considered when relevant1. The patient perspective and notably their quality of life, will need to be sufficiently considered including via patient-reported experiences and outcomes measurements (PREMs; PROMs). The perspective of families and carers should be also included.

Applicants should consider leveraging relevant large datasets that are already available at national and / or European level.

Ensuring data quality will be of paramount importance. In addition, applicants should ensure trustworthy and safe sharing of patient data through ‘privacy and security by design’. They should also give ample consideration for the control of data reuse by patients and healthcare professionals, for example by the implementation of ‘FAIR’ data principles and a suitable data governance structure.

The platform should build on suitable existing platforms or elements thereof (for example specialised research infrastructures, including those developed by IMI projects) with proven efficiency and interoperability, complying with European privacy and security requirements and enabling integrated workflows of data management, curation, and analysis to amplify the intrinsic value of the datasets. Its design should allow for future expansion as well as continuous updates in a secure environment, plus potential integration with other platforms and easy adaptation for use in other health areas.

Advanced analytical and workflow tools (including artificial intelligence (AI)-based) and, where relevant, predictive simulations should be proposed which enable improved analysis of the integrated patient data in combination with clinical insights and expertise to optimise best practice guidelines, support better clinical decision-making and assessment of outcomes for optimised care pathways, bespoke to the patient and the healthcare system.

Applicants should also consider how the proposed solutions could be part of integrated community-based health and social services that optimise independence, quality of life and the wellbeing of the individual, including when relevant behavioural changes, while decreasing the burden on families and carers.

Applicants providing data as part of their applications should include in the proposals evidence that all legal, ethical, and intellectual property permissions are in place to ensure the availability of the data to the consortium.

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HORIZON-MISS-2022-CANCER-01-05

Establishing of national cancer mission hubs and creation of network to support the Mission on Cancer

Indicative budget: € 3 million
Opening: 24 May 2022
Deadline: 27 September 2022

Keywords: cancer; network; policy dialogue; awareness raising; employment; education; socio-economic aspects

Expected Outcome

The integration of the Mission on Cancer with activities at national, regional and where relevant at local level will be of utmost important to ensure its success. Taking into account the differences of national health and research and innovation systems, the coordination and support of cancer mission-related activities at national, regional and where relevant at local level are essential in this regard. At the same time, synergies with actions under Europe’s Beating Cancer Plan need to be generated.

The successful proposal should aim at delivering results that are directed at and contributing to all of the following expected outcomes:

  • The activities of the Mission on Cancer are integrated with activities at national, regional, and local levels;
  • Actors in national, regional or local health and research and innovation systems are engaged in the policy dialogue on cancer;
  • Citizens, including patients, and national, regional and local stakeholders are engaged in the policy dialogue on cancer.

Scope

A national cancer mission hub will be established in each Member State and Associated Country. Its activities will include awareness raising and coordination of the Mission’s activities among and with relevant actors in national, regional or local research and innovation and health systems, while also generating and leveraging synergies with Europe’s Beating Cancer Plan, thus fostering an enhanced policy dialogue on cancer control at national, regional or local level. Hence, the activities will be complementary to the ones of the National Contact Points that focus on Horizon Europe Work Programmes[1]. National cancer mission hubs will be established either by building on existing structures (e.g. mirror groups) or by creating new ones.

Notably these hubs will:

  • Facilitate integration of the activities of the Mission on Cancer at national, regional, and local levels e.g. identifying synergies between European, national, regional and local policies and initiatives related to cancer;
  • Facilitate engagement of relevant actors and stakeholders at national, regional or local level going beyond the research and innovation and health systems to cover all relevant areas in cancer control and support policy dialogues on cancer (examples include employment, education, socio-economic aspects);
  • Support citizen engagement activities at national, regional and local levels, including new participatory formats.

The proposed activities of national cancer mission hubs should be closely linked with those of the established National Contact Points (NCPs) under Horizon Europe, the National Focal Points (NFP) supporting the EU4Health programme and those of the contact points of other EU funding programmes[2].

The national cancer mission hubs should operate for the whole duration of the Cancer Mission. As the volume and nature of activities is likely to evolve over time, the support for national mission hubs will be provided in two phases. This first phase will have a duration of 3 years (2023-2025). The support provided in the second phase will build on the achievements and needs identified during the first phase.

The Commission may facilitate Mission-specific coordination through future actions, such as the successful proposal TRAMI resulting from the topic HORIZON-MISS-2021-COOR-01-01, “Coordination of complementary actions for missions”. Therefore, the successful proposal 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 and project duration. In this regard, the Commission will take on the role of facilitator for networking and exchanges, including with relevant initiatives and stakeholders, if appropriate.

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HORIZON-MISS-2022-CANCER-01-04

Towards the creation of a European Cancer Patient Digital Centre

Indicative budget: € 3 million
Opening: 24 May 2022
Deadline: 27 September 2022

Keywords: digital centre; cancer; patient-centered approach; health data; prevention; diagnosis; treatment guidelines; treatment side-effects; guidance & support

Expected Outcome

The overall goal of the Mission on Cancer[1] and the Europe’s Beating Cancer Plan[2] includes a better quality of life for patients and their families living with, and after, cancer.

Project results will support the creation of a virtual European Cancer Patient Digital Centre (ECPDC), which is a federated network of patient controlled (national) health data infrastructures enabling the voluntary exchange of patients and survivors’ health data in a standardised approach, for primary and secondary use.

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:

  • Citizens, including cancer patients and survivors, are able to donate, access and manage their own clinical data, including patient-reported outcomes (PRO), and have control over the access to these data in a secure, standardised, ethical and interoperable manner.
  • Citizens, including cancer patients and survivors, their families and caregivers have access to and use the ECPDC as a global centre of knowledge on cancer, including on prevention, diagnosis, treatment guidelines, treatment side-effects, access to cross-border health care, psychosocial and legal support, including guidance and support on returning to work, addressing financial issues and asserting survivors’ rights.
  • Tools are provided to clinicians allowing them to collaborate with patients to develop the best methods of care and personalized treatments regardless of their location.
  • Citizens, including cancer patients and survivors, receive information on personalised care through the ECPDC, which monitors data trends and provide insights on treatment side effects and other outcome measures based on standardised patient-reported outcome and experience measures, by aggregating and analysing large data sets using state-of-the-art secure cloud computing and data analytics and visualisation methods and tools, including AI.
  • Citizens, including cancer patients and survivors, are empowered in co-deciding on their care as well as in participating in research. The rights of patients are reinforced and their confidence in sharing their data for cancer research, innovation and policy development is increased.
  • Researchers, citizens, including cancer patients and survivors, and policy-makers have access to a valuable resource of aggregated patient data that are evolving over time, to correlate different sources of information and whereby disease trajectories of patient’s and survivor’s health could be inferred. This will improve the knowledge and understanding of cancer and its impact on the lives of citizens, including cancer patients and survivors, thus contributing to the development of improved diagnostics, treatment, care and quality of life support and to the development of policies.

Scope

Patient-controlled health data networks in Europe show a high level of heterogeneity with regard to the involvement of EU Member States, as well as the types and interoperability of collected data, organisation and governance of data storage, its access and security, and the possibility to reuse data for research purposes.

Proposals should address the existing challenges and develop a roadmap towards the creation of the ECPDC as a virtual, federated network of national infrastructures of patient-controlled health data (‘national or regional nodes’), taking into account synergies with the future UNCAN.eu platform, integrated within a larger European network of infrastructures, to which each Member State should have a single access portal.

The proposals should draw on existing expertise at the EU[3] and national level and on EU- and Member State/Associated Country-tailored procedures for access, use and re-use of patient data. Moreover, synergies with the European Network of Cancer Registries[4] should be established to ensure the ECPDC will create an ecosystem on knowledge of cancer. It could also include a call centre function.

In particular, proposals should take account of the results of a recently launched call on a pilot project for an EU infrastructure ecosystem for the secondary use of health data for research, policy-making and regulatory purposes[5], the future EU legislation on European Health Data Space (EHDS)[6], the future Cancer Survivor Smart-Card[7], the cancer use case under the 1+Million Genomes initiative (1+MG)[8], the Cancer Imaging Initiative[9] as well as the European Open Science Cloud[10]. Successful applicants will be asked to liaise with these different initiatives where applicable[11], with the Commission acting as a facilitator.

Accordingly, proposals should cover all of the following activities:

  • Actively engage and facilitate assessment of relevant existing patient-controlled health data networks at the EU and Member State/Associated Country level, to assess how the ECPDC will integrate and interact with existing national care pathways and the IT systems. A multidisciplinary team, including also users such as patients, care professionals and researchers, should be involved in the development of the proposed federated network.
  • Develop a roadmap outlining the necessary intermediate steps towards the creation of the federated network of national health data infrastructures, including technical requirements, governance aspects and timelines.
  • Design and perform a testing phase of the network before its release, allowing the adjustment of its tools/functionalities, validate the proposed approach and inform on how it could be scaled and sustained.
  • Analyse and provide solutions for extraction of health data, e.g. from the electronic health records, genomic databases (e.g. 1+MG)[8], the Cancer Imaging Initiative[9] and the future Cancer Survivor Smart-Card[14]. Data protection rules should be taken into account.
  • Analyse and provide solutions for cross-border transfer of personal data and options to access and store patient data, taking into account the eIDAS, GDPR, other EU and national legislations, and the integration of the ECPDC within the European Health Data Space.
  • Establish robust communication and effective information exchange between diverse actors such as cancer patients and survivors, formal and informal caregivers, policy makers and researchers.

The funded actions should build upon resources made available by the Knowledge Centre on Cancer[15], and complement actions under the Europe’s Beating Cancer Plan[16], including the Cancer Imaging Initiative[17], and the future European Health Data Space[18].

Furthermore, all projects funded under this topic are strongly encouraged to participate in networking and joint activities with other ongoing projects under the mission on cancer (especially with UNCAN.eu) and other cancer relevant projects, 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.

The Commission may facilitate Mission-specific coordination through future actions. 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 and project duration. In this regard, the Commission will take on the role of facilitator for networking and exchanges, including with relevant initiatives and stakeholders, if appropriate.

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HORIZON-MISS-2022-CANCER-01-03

Pragmatic clinical trials to optimise treatments for patients with refractory cancers

Indicative budget: € 60 million
Opening: 24 May 2022
Deadline: 27 September 2022

Keywords: clinical trials; refractory cancers; patient-centered approach; reaseach & innovation; COVID-19

Expected Outcome

While cancer research and innovation have generated novel treatment options, cancer patients across Europe need access to more effective and patient-centred interventions which keep up with increasing demands in a complex and fragmented oncology healthcare landscape with spiralling healthcare costs.

Furthermore, the COVID-19 pandemic with its detrimental impact on cancer control has demonstrated the need for different clinical trial designs with fewer inclusion and exclusion criteria that would allow evaluation of real-world effectiveness driving better and more affordable treatment solutions that are widely accessible across EU regions, Member States and Associated Countries.

Pragmatic clinical trials focus on choosing between care options. Pragmatic trials evaluate effectiveness, the effect of treatment in routine (real-world) clinical practice. Some examples include treatment versus active surveillance in patient management, combination of treatment interventions, determination of optimal dose and dose schedule, de-escalation of treatment intervention, comparative effectiveness of different treatment interventions.

Proposals under this topic should aim for delivering results that direct, tailor towards and contribute to all of the following expected outcomes:

  • Cancer patients and their caregivers will have access to optimised and affordable treatment interventions that increase their quality of life, across EU regions, Member States and Associated Countries;
  • Healthcare professionals and academia will generate clinical evidence, by evaluating effectiveness in randomised or cluster-randomised academic investigator-initiated[1] pragmatic clinical trials, how to best perform and deploy evidence-based treatment interventions that improve outcomes in real life for routine healthcare, including quality of life, for cancer patients who often present with co-morbidities;
  • National healthcare providers, policymakers and authorities in EU Regions, Member States and Associated Countries will have the evidence to implement optimised and affordable treatments in their healthcare systems, including in everyday medical practice.

Scope

Proposals should address all of the following:

  • Design and conduct randomised or cluster-randomised academic investigator-initiated pragmatic clinical trials to deliver effective and evidence-based treatment interventions for implementation by healthcare systems at the level of local communities, EU Regions, Member States and Associated Countries, taking into account socio-economic and biological stratification, such as biology of the disease, gender, cancer stage, and age.
  • The chosen treatment intervention(s)[2] should be adapted to the particular needs of the target population and to the specificities of the provision of care at local, regional, or national level, duly reflecting the diversity across Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account.
  • The successful proposals will address treatment interventions for patients with refractory cancers (cancers with a 5-year overall survival of less than 50% from time of diagnosis) at any stage of the disease, for any cancer subtype, in any age group or part of society.
  • The successful proposals should clearly justify and describe the evidence supporting the chosen treatment intervention.
  • The primary and secondary endpoints of the pragmatic clinical trial should target overall survival, patient-preferred clinical benefit, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers. Such endpoints should be defined together with patients and their caregivers through research models that use open knowledge, (social) innovation systems and support end-user engagement (e.g. living labs).
  • Implementers of pragmatic clinical trials and trial results should include physicians, academia, patients and their caregivers, patient representatives, payers, charities and foundations, research organisations, civil society, regional and national research and innovation organisations, and health authorities.
  • Successful pragmatic clinical trials, including their analyses, should be completed within 5 years after the start of the project. Translational research is not within the scope of this topic.
  • In all instances, sex- and gender-related issues must be taken into account. All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status.

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 with other ongoing projects under the mission on cancer and other cancer-relevant projects, 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.

The Commission may facilitate Mission-specific coordination through future actions. 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 and project duration.

In this regard, the Commission will take on the role of facilitator for networking and exchanges, including with relevant initiatives and stakeholders, if appropriate.

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HORIZON-MISS-2022-CANCER-01-02

Strengthening research capacities of Comprehensive Cancer Infrastructures

Indicative budget: € 10 million
Opening: 24 May 2022
Deadline: 27 September 2022

Keywords: comprehensive cancer infrastructures; comprehensive cancer centres; capacity building programme; digital, research & innovation-related capacities

Expected Outcome

The Mission Board of the EU Mission on Cancer has defined Comprehensive Cancer Infrastructures as ‘national or regional infrastructures that provide resources and services to support, improve and integrate cancer care, research, training of care professionals and education for cancer patients, survivors and families/carers.

Today, the level of development of Comprehensive Cancer Infrastructures and their capacities, such as their digital, research and innovation-related capacities, vary considerably across Member States and Associated Countries, leading to inequalities, in particular in terms of research, quality and access to care.

The Horizon Europe Mission on Cancer will complement the set-up across Member States and several Associated Countries of an EU network of Comprehensive Cancer Centres that will be established through the Europe’s Beating Cancer Plan by 2025. The Mission aims to achieve the target of ensuring that 90% of eligible cancer patients have access to Comprehensive Cancer Infrastructures by 2030. In that context, this topic should set up, across Member States and several Associated Countries, a capacity-building programme for countries of the EU network of Comprehensive Cancer Centres to be established through the Europe’s Beating Cancer Plan[1], to support them in improving or developing their existing or future Comprehensive Cancer Infrastructures, focussing on developing their digital, research & innovation-related capacities and their integration with cancer care.

Proposals under this topic should aim at delivering results that are directed at and contributing to all of the following expected outcomes:

  • Research and health policy makers will benefit from support to further develop or set up Comprehensive Cancer Infrastructures, leading to improvement in terms of research and access to care;
  • Research and healthcare professionals will benefit from a better integration between research and care;
  • Researchers will benefit from innovative infrastructures to perform research and participate in studies;
  • Citizens, including patients and their caregivers will have enhanced access to screening, diagnostics and treatments, improved care pathways and more integrated care. Their involvement and participation to clinical trials will be facilitated.

Scope

Building inter alia on the work carried out in several joint actions[2], the work of organisations in the area of accreditation and certification[3], the work that will be carried out under the Europe’s Beating Cancer Plan[4], as well as existing[5] and potential future mappings, a capacity-building programme should be set up for Member States and several Associated Countries in the EU network of Comprehensive Cancer Centres, to be established through the Europe’s Beating Cancer Plan, in order to help them develop or further improve digital, research & innovation-related capacities of future or existing Comprehensive Cancer Infrastructures.

Proposals should address all of the following:

  • The capacity-building programme should be organised over the course of three years, with at least one training session taking place in each Member State and those Associated Countries in the EU network of Comprehensive Cancer Centres, to be established through the Europe’s Beating Cancer Plan. In the planning of the capacity-building programme, sufficient time should be allocated to ensure proper follow-up and implementation of the recommendations provided to the participating countries.
  • Each training session shall be tailored to the needs of the participating country. These needs shall be identified and discussed with the participating country prior to the session. This concerns in particular the required participants / stakeholder groups, duly reflecting health and research system specificities.
  • The capacity-building programme should start in countries with no existing Comprehensive Cancer Infrastructure, followed by those with some existing Comprehensive Cancer Infrastructures but needing substantial improvement, and then support the further development of Comprehensive Cancer Infrastructures in countries with an already established system.
  • The training sessions shall consist of balanced theoretical and practical parts, including simulations, case studies, group exercises, mutual learning exercises and on-the-spot visits (when possible) to gather practical experience.
  • At the end of each training session, a report shall be produced indicating the areas identified for improvement and suggesting recommendations and a follow-up for the participating country. This should include information on available EU (funding) instruments as well as any other suitable sources of support for the areas identified for improvement.
  • After the initial session, the project should provide an on-demand support service to the participating country(ies) to ensure proper follow-up and support for the implementation of the recommendations provided.
  • Proposals should consider, as part of this follow-up, to invite the country to participate to a supplementary and more focused session. The possibility of a twinning activity with another country which is more advanced on the areas identified for improvement should be explored as part of this follow-up.
  • Proposals should consider including the following areas of development or improvement of future or existing Comprehensive Cancer Infrastructures in their capacity building activities:
    • Enhanced involvement in and quality of scientific research, including development and participation to clinical trials and epidemiological studies (e.g. clinical trial design, process of trial approval, ethical aspects, recruitment, staffing and training requirements including digital skills, organisational aspects, regulatory requirements, core facilities, patient participation and empowerment (in the planning and implementation of patient-oriented cancer research);
    • Better integration between research and care programmes;
    • Improvement of patient care pathways and integrated care;
    • Development and use of indicators (e.g. quality, outcomes) and registries;
    • Implementation of quality assurance and related standards;
    • Support in accreditation and certification;
    • Networking capacities (within and across Member States), including through improvement of data exchange capacities (e.g. interoperability and data protection related aspects);
    • Gender-related aspects (with respect to representation in research and career pathways and any other relevant aspects).
  • At the end of the capacity-building programme, an overall report shall be produced, highlighting transferable best practices and lessons learned from the capacity-building programme and the support provided.

Due consideration should be given to other relevant EU-funded initiatives[6]. This capacity-building programme should be built and conducted in full synergy and complementarity with the actions foreseen under the Europe‘s Beating Cancer Plan[7], with the Commission acting as a facilitator.

The funded action should build upon resources made available by the Knowledge Centre on Cancer[8].

Furthermore, the project funded under this topic is strongly encouraged to participate in networking and joint activities with other ongoing projects under the mission on cancer and other cancer relevant projects, 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.

The Commission may facilitate Mission-specific coordination through future actions. 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 and project duration. In this regard, the Commission will take on the role of facilitator for networking and exchanges, including with relevant initiatives and stakeholders, if appropriate.

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HORIZON-MISS-2022-CANCER-01-01

Improving and upscaling primary prevention of cancer through implementation research

Indicative budget: € 50 million
Opening: 24 May 2022
Deadline: 27 September 2022

Keywords: cancer; implementation research; primary prevention

Expected Outcome

For an increasing number of cancer indications potential mechanisms and means to prevent the onset of cancer have been identified[1]. However, with cancer incidence steadily increasing across all age groups, parts of society, European Member States, Associated Countries and elsewhere[2], decisive action on primary prevention should be stepped up and made a collective responsibility. Implementing and upscaling of primary cancer-centred prevention programmes would contribute to achieving this goal.

Adoption and efficacy of primary cancer prevention programmes in real-life has been insufficient, due to factors related to local context, such as organisation and digitalisation of healthcare services, resources, cultural, and geographical situation. To appropriately adapt interventions and scale-up to different geographical, economic and cultural settings, proposals should aim at delivering results through implementation research[3], which are directed, tailored towards and contributing to all of the following expected outcomes:

  • Citizens will benefit from the outcomes of evidence-based, tailored and affordable primary prevention programmes targeting known cancer risk factors and health determinants, including behavioural factors, that are tailored to the specific needs of local communities and effectively adopted;
  • Healthcare professionals and patient organisations will be able to provide evidence-based information targeted at individuals and families on cancer prevention, including through vaccination, improved health literacy, issuing of better guidelines and counselling;
  • Regional and national policymakers and authorities will engage in implementing and scaling-up the most suitable prevention programmes, including possible legislative policies;
  • Civil society, charities, foundations, and innovators will seize opportunities to further upscale and innovate primary prevention programmes at local, urban, rural, regional, national or international level.

Scope

Investments are needed to establish, scale-up or improve primary cancer prevention programmes. The barriers that prevent their uptake and effective implementation should be identified and addressed. Also, primary cancer prevention programmes should be tailored to the particular needs of the target populations, taking into account socio-economic, cultural and geographical conditions. Digital tools and datasets may be considered where needed.

Proposals should address all of the following:

  • Focus on implementation and upscaling of evidence-based primary cancer prevention interventions, at local, regional or national level, addressing known risk or protective factors and determinants[4]. Proposals should clearly justify and describe the existing evidence supporting the chosen intervention, including evidence of cost-effectiveness and affordability, across health or other sectors.
  • As effective prevention includes behavioural change, due consideration should be given to the factors that facilitate or impede behavioural change.
  • Identify and address the bottlenecks and barriers that might influence uptake and implementation of cancer prevention programmes in accessible, affordable and equitable ways, and their impact in a defined public health context.
  • Provide evidence and recommendations to inform policy and decision-makers and propose a pathway to integrate the intervention into local, regional or national health systems, policies and practices.
  • Applicants are required to co-create with relevant stakeholders, including representatives of citizens, people at risk of cancer, patients, survivors, health practitioners, payers, and policymakers in the design and conduct of research and evaluation of its outcomes. Such partners will be integral to the success and sustainability of the programme and it is essential that they are engaged early in the definition of problems and barriers.
  • Proposals should align with commitments or planned commitments at a regional or country level to implement evidence-based interventions. Researchers should collaborate closely with responsible authorities. The latter should provide the interventions and the financial means.
  • Approaches, methodologies and frameworks used should be specific to implementation science, and based on appropriate outcomes, such as feasibility, acceptability, sustainability, uptake and cost effectiveness.
  • The design of the proposed interventions should take the gender dimension and ethics into account, and contribute to reducing health inequalities.
  • The organisational and resource requirements (data, digital tools, personnel and financing) necessary for the implementation of the intervention must be described, tracked and evaluated in detail. The research and system-wide scientific monitoring should allow future users (researchers, healthcare providers, policy makers, and the public) to review the step-by-step, partial outcomes of the intervention, thus facilitating a wider adoption of these practices. The appropriate contextual, financial and political-economic analyses should be provided.

Clinical trials and translational research are not within the scope of this topic.

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 should demonstrate awareness of relevant projects on implementation research in primary cancer prevention[5]. Successful applicants will be asked to liaise with these different initiatives where applicable[6], with the Commission acting as a facilitator. Where applicable, funded actions should make use of resources made available by the Knowledge Centre on Cancer[7].

Furthermore, all projects funded under this topic are strongly encouraged to participate in networking and joint activities with other ongoing projects under the mission on cancer and other cancer relevant projects, 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.

The Commission may facilitate Mission-specific coordination through future actions. 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 and project duration. In this regard, the Commission will take on the role of facilitator for networking and exchanges, including with relevant initiatives and stakeholders, if appropriate.

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HORIZON-HLTH-2022-STAYHLTH-01-05-two-stage

Prevention of obesity throughout the life course

Indicative budget: € 60 million (6 projects at 10 million per project)
Opening: 6 October 2021
Deadline: 1 Feb 2022 (First Stage), 6 Sep 2022 (Second Stage)

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

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 for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Researchers, developers of medical interventions, and health care professionals have a much better understanding of basic biological pathways (genetic and epigenetic blueprints) conferring susceptibility to and protecting against overweight/obesity, i.e. how genetic, epigenetic, environmental, socio-economic and lifestyle factors interact to drive or prevent the transition from normal weight to overweight/obesity throughout the life course.
  • Health care professionals, national/regional/local public authorities and other relevant actors (e.g. schools, canteens, hospitals, work places, shopping malls, sport centres):
    • Have access to, adopt and implement evidence-based clinical guidelines, best practices, coordinated, pan-European, multidisciplinary preventive strategies, policy recommendations and/or new policies to fight overweight/obesity and their co-morbidities throughout the life course.
    • Have access to and make use of a robust outcomes framework and tool-kit for standardised collection of economic and cost data related to the prevention and treatment of overweight/obesity and its co-morbidities at population level across European regions and countries.
    • Adopt and implement tailor-made prevention campaigns to tackle overweight/obesity, including campaigns for improving integration of health education into academic learning and raising awareness of health care providers and citizens.
  • Citizens have access to and make use of new tools and services to make informed decisions about lifestyle choices that will prevent them from becoming overweight/obese.

Scope

Obesity is one of the most serious public health challenges of the 21st century. Although health has improved in the EU over the last decades, the prevalence of obesity has tripled in many countries of the EU. It is known that once individuals become overweight or obese, they are at risk of developing related diseases (diabetes, cardiovascular diseases, cancer). Overweight and obesity are largely preventable. In the current pandemic, the issue of overweight/obesity has become even more prominent, highlighting the need for prevention of overweight/obesity.

Increased efforts in research and innovation are critical for developing and testing the impact of tools, initiatives, interventions, strategies, programmes, policies and their implementation to prevent overweight/obesity. The use of best practices, harmonisation guidelines and/or standard operating procedures, developed at various levels (from local to national) in the EU and beyond, will be the foundation for new research.

Cultural diversity, urban/rural dichotomy, socio-economic status, age groups, sex and gender differences should be investigated, where relevant. Strong collaborations across sectors and with other European projects dealing with issues such as agriculture, aquaculture, food, environment, etc. are welcome. Proposals should engage citizens, civil society organisations (e.g. employers/employee organisations, charities), authorities (e.g. municipalities and health authorities) and institutions (schools, canteens, hospitals, work places, shopping malls, sport centres), local producers, etc. in the development of their actions to ensure acceptability and deployment. Proposals should aim to develop scientifically robust and transparent methodologies, building on achievements from previous research activities.

Proposals should address several of the following research bottlenecks:

  • A comprehensive understanding of biological pathways (genetic, epigenetic, molecular, microbiome, and/or neuroimmune) conferring susceptibility to and protecting against uncontrolled “weight gain”.
  • Identification of socio-economic and lifestyle factors influencing consumer behaviour and their association to overweight/obesity prevention.
  • Identification of pre-obesity biomarkers (genetic, laboratory, imaging, etc.) and their association to lifestyle and environmental interventions aiming at obesity prevention and tailored to specific target populations.
  • Mapping existing implementation research activities to prevent overweight/obesity, outcome analyses and identification of best practices.
  • Conducting a thorough meta-review of information from available scientific literature and identification of the relationship between the risk for overweight/obesity and the biology of obesity, lifestyle habits, exposures, susceptibility to co-morbidities and/or all of their combinations.
  • Developing recommendations and guidelines for what constitutes an appropriate healthy diet for different age and health groups.
  • Understanding the causal links between overweight/obesity and sedentary behaviour, quality and quantity and types of food/drinks, physical activity, and personality traits.
  • Designing a creative and engaging programme to reach the optimal balance between diets and physical activity for the prevention of overweight/obesity.
  • Analysing obesity stigma, stress and work-life balance, circadian rhythm disruption, mental health (including psychological problems), screen-time dependency, drugs and side effect of drugs, for the prevention of overweight/obesity.
  • Addressing inequality aspects of overweight/obesity at multiple levels, taking into account vulnerable groups, gender and socio-economic factors.
  • Setting up pilots to assess the effectiveness of obesity management strategies, including cost-effectiveness, and analyse the impact of inactions, taking into account co-morbidities and value-based care system.
  • Developing a system for monitoring population indicators relevant to overweight/obesity by extending European Core Health Indicators.

Proposals should adopt a patient-centred approach that empowers patients, promotes a culture of dialogue and openness between health professionals, patients and their families, and unleashes the potential of social innovation.

Proposals could consider the involvement of the European Commission’s Joint Research Centre (JRC) whose contribution could consists of providing added-value regarding aspects of healthier school environments, effectiveness of policies influencing food preferences as well as improving the food offer and food environment.

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, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover 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.

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HORIZON-HLTH-2022-DISEASE-06-04-two-stage

Development of new effective therapies for rare diseases

Indicative budget: € 60 million (8 projects at 8 million per project)
Opening: 6 October 2021
Deadline(s): 1 Feb 2022 (First Stage), 6 Sep 2022 (Second Stage)

Keywords: novel therapy, rare diseases, multidisciplinary, novel preclinical models/tools, verification of therapeutic targets, proof-of-concept clinical studies

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 some of the following expected outcomes:

  • Researchers and developers make the best use of the state-of-the-art knowledge and resources for a fast and effective development of new therapies for rare diseases.
  • Researchers and developers increase the development success rate of therapies for rare diseases by employing robust preclinical models, methods, technologies, validated biomarkers, reliable patient reported outcomes and/or innovative clinical trials designs.
  • Developers and regulators move faster towards market approval of new therapies for rare diseases (with currently no approved treatment option) due to an increased number of interventions successfully tested in late stages of clinical development.
  • Healthcare professionals and people living with a rare disease get access to new therapeutic interventions and/or orphan medicinal products.

Scope

Despite the considerable amount of knowledge that has been accumulated and the new orphan medicines developed in recent years, the number of available therapies for rare diseases remains low, as fewer than 6% of rare diseases have an approved treatment option.
The joint evaluation123of the regulations on orphan medicinal products and paediatric medicines concluded that those regulations have boosted the development for new therapies for rare diseases but have not yet adequately managed to direct research and innovation in areas of greatest unmet medical need. Actually, there is an urgent unmet medical need for the development of therapies for rare diseases, where there is still no approved therapeutic option available.

Therefore, proposals should aim to develop therapies for rare diseases with no approved therapeutic option. Proposals should focus on group(s) of rare diseases with commonalities, such as shared biological features, possibly within the same and/or across different medical areas within the rare diseases landscape124. Thus, proposals should not address a single disease only (for example with an Orphacode representing a single disease).

The therapies to be developed may include a broad family of therapeutic interventions such as small molecule(s), advanced therapy medicinal products, repurposing of existing medicinal products, including non-pharmacological interventions and/or their combinations, as relevant. Sex and gender aspects should be considered, where relevant. To ensure that the needs of people living with a rare disease are adequately addressed, the involvement of patient representatives in all phases of the research and development process is strongly encouraged. Rare infectious diseases and rare cancers are excluded from this topic and will not be considered.

The topic will support proposals covering several different stages in the continuum of the innovation pathway (i.e. translational, preclinical, clinical research, validation in the clinical and/or real-world setting etc.), as relevant. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations for the benefit of people living with a rare disease.

The proposals should address most of the following research activities:

  • Establish multidisciplinary collaborations between all relevant stakeholders by integrating disciplines, technological developments and existing knowledge. Integrate harmonised data from multiple sources (i.e. natural history studies/clinical trials, multi-omics, medical imaging, registries etc.) by utilising data analytics and/or other suitable methods, with the aim to understand the pathophysiology/heterogeneity of the rare diseases concerned and to identify therapeutically actionable mechanisms.
  • Develop and utilise relevant preclinical models and/or innovative tools/technologies to: verify molecular/cellular pathways/genes that can be therapeutically targeted, increase the confidence in the targets selection and/or perform toxicity studies. When using disease models the applicants should describe how well the model replicates the pathology or the human condition.
  • Develop and/or execute innovative clinical trials designs for small populations and novel approaches to assess and monitor the safety and efficacy of the proposed interventions. Such approaches may include but are not limited to: biomarkers defining robust surrogate and clinical endpoints; artificial intelligence tools/medical devices/biosensors/ companion/ complementary diagnostics for defining reliable patient reported outcomes; modelling and simulation and in-silico trials methodologies.
  • Carry out preclinical proof-of-concept (PoC) studies and/or multinational interventional clinical studies125 to demonstrate the safety and efficacy of the therapeutic interventions under study. Preclinical PoC studies should include late-stage preclinical studies (i.e. toxicological properties, adverse effects etc.). Clinical studies may cover all necessary development stages. Applicants should propose a clear exploitation pathway through the different necessary steps (research, manufacturing, regulatory approvals and licensing, IP management etc.) in order to accelerate marketing authorisation and uptake by the health systems.

Proposals should involve group(s) of rare diseases (i.e. a rare disease being individually defined in the European Union as affecting not more than five in 10.000 persons). Proposals that plan to run clinical trials should demonstrate that they have already taken into account scientific advice or protocol assistance from EMA. In particular, proposals planning the clinical development of orphan medicinal products should demonstrate that they have been granted approval for an orphan designation at the latest on the date of the call deadline.

Proposals should adhere to the FAIR data principles and take stock, wherever relevant, of data standards, harmonisation guidelines and good practices for data sharing/access developed by existing European health research infrastructures (i.e. ESFRI infrastructures). Proposals should take stock, where relevant, of the FAIR guidance, of good practices for analytical methods and preclinical models and of good exploitation strategies for the translation of research results into high impact interventions, developed by the European Joint Programme on Rare Diseases (EJP RD) and other relevant EU-funded projects. Whenever the proposed data sources or fields of application include genomics, the proposals should take into account, where relevant, the data standards, and legal, ethical and technical interoperability requirements and guidelines agreed within the 1+ Million Genomes initiative. Data-intensive proposals, particularly those using data from patient registries, could consider the involvement of the European Commission’s Joint Research Centre (JRC) and take stock of the tools and services provided by the European Platform on Rare Disease Registration (EU RD Platform), including the adoption, where relevant, of the European standards such as the “set of common data elements”. In addition, synergies should be sought with the European Reference Networks, where relevant.

Projects funded under this topic will contribute towards the goals of the International Rare Diseases Research Consortium (IRDiRC) that supports the development of 1000 new therapies for rare diseases by 2027 and may take stock of the IRDiRC Orphan Drug Development Guidebook, where relevant.

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HORIZON-HLTH-2022-STAYHLTH-01-04-two-stage

Trustworthy artificial intelligence (AI) tools to predict the risk of chronic non-communicable diseases and/or their progression

Indicative budget: € 60 million (6 projects at 10 million per project)
Opening: 6 October 2021
Deadline(s): 1 February 2022 (First Stage), 6 September 2022 (Second Stage)

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

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 1 “Staying healthy in a rapidly changing society”. 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.

  • Clinicians, medical professionals and citizens have access to and use validated AI tools for disease risk assessment. Hence, citizens are better informed for managing their own health.
  • Health care professionals utilise robust, trustworthy and privacy-preserving AI tools that help them to assess and predict the risk for and/or progression of chronic non-communicable diseases. Hence, citizens benefit from improved health outcomes.
  • Health care professionals develop evidence-based recommendations and guidelines for the implementation of AI-based personalised prevention strategies. Hence, citizens benefit from optimized health care measures superior to the standard-of-care.
  • Health care professionals employ quantitative indicators in order to identify and follow-up on individuals with high risk for the development and/or risk for the progression of chronic non-communicable diseases.

Scope

It is widely recognised that health systems must put more emphasis on prevention and adopt a person-centred approach. Artificial intelligence (AI) along with the increased availability of health data hold great potential to pave the way for personalised prevention and enable progress towards risk prediction and early detection of chronic non-communicable diseases.

This topic will support multidisciplinary research, build on broad stakeholder engagement and support proposals developing novel robust and trustworthy23 AI tools to enable timely personalised prevention approaches for chronic non-communicable diseases/disorders. The topic does not exclude any diseases/disorders.

Proposals are expected to develop and test AI tools for assessing and predicting the risk of developing a disease and/or the risk of disease progression once it is diagnosed, taking into account the individuals’ (or groups) genotypes, phenotypes, life-style, occupational/environmental stressors and/or socio-economic and behavioural characteristics, as necessary. Sex and gender aspects should be considered, wherever relevant.

The AI tools may include a broad range of technological solutions on their own and/or in combination with other relevant state-of-the-art technologies (i.e. AI algorithms, mobile apps and sensors, robotics, e-health tools, telemedicine etc.)
Proposals should implement proof-of-concept studies to test and validate the performance of their AI tools in the real-world setting and compare their performance to the established practice.

The applicants should ensure that the AI tools developed are driven by relevant end-users/citizens/health care professionals needs. Therefore, the proposals are expected to introduce concrete measures for the involvement of the end-users throughout the AI development process and not only in the last phases of development. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations for the people’s benefit.

Proposals should address all of the following:

  • Leverage existing high-quality health-relevant data from multiple sources (i.e. cohorts, electronic health records and registries, taking into account the individual’s genotypic/phenotypic, medical, life-style, socio-economic, behavioural data etc.) and/or generation of new high-quality health data necessary for the rigorous development of the AI disease-risk tools.
  • Develop the adequate performance metrics to assess the technical robustness of the developed AI tools for risk assessment of disease and/or disease progression and in particular their accuracy, reliability, reproducibility and generalisability. Proposals should assess the possible inherent bias introduced to the AI tools originating from the data quality used for their development.
  • Develop the criteria to assess the effectiveness of the AI tools for disease risk assessment in terms of improving health outcomes and enabling personalised prevention strategies.
  • Implement proof of concept and/or feasibility studies to validate the AI tools for risk assessment of disease and/or disease progression in a relevant end-users environment and/or real-world setting and assess their performance in comparison to the standard-of-care.

Proposals should adhere to the FAIR data principles and apply good practices for GDPR-compliant personal data protection. Proposals are encouraged to implement international standards and best practices used in the development of AI solutions.

Integration of ethics and health humanities perspectives to ensure an ethical approach to the development of AI solutions. In relation to the use and interpretation of data, special attention should be paid to systematically assess for gender and ethnic bias and/or discrimination when developing and using data-driven AI tools.

To ensure citizens’ trust, wide uptake by user communities and scalability of the solutions across clinical contexts, actions should promote the highest standards of transparency and openness of the AI tool, going well beyond documentation and extending to aspects such as assumptions, architecture, code and underlying data.

Applicants are highly encouraged to deliver a plan for the regulatory acceptability of their technologies and to interact at an early stage with the regulatory bodies, whenever relevant.

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, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover 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.

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HORIZON-HLTH-2022-TOOL-12-01-two-stage

Computational models for new patient stratification strategies

Indicative budget: € 60 million (10 projects at 6 million per project)
Opening: 6 October 2021
Deadline(s): 1 February 2022 (First Stage), 6 September 2022 (Second Stage)

Keywords: patient stratification, health data integration, data-driven computational tools, evidence-based guidelines

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, tailored and contributing to some of the following expected outcomes:

  • Clinical researchers use effective health data integration solutions for the classification of the clinical phenotypes.
  • Researchers and/or health care professionals use robust and validated data-driven computational tools to successfully stratify patients.
  • Regulatory bodies approve computer-aided patient stratification strategies to enable personalised diagnosis and/or personalised therapy strategies.
  • Health care professionals adopt evidence-based guidelines for stratification-based patient management superior to the standard-of-care.

Scope

In the era of big and complex data, the challenge remains to make sense of the huge amount of health care research data. Computational approaches hold great potential to enable superior patient stratification strategies to the established clinical practice, which in turn are a prerequisite for the development of effective personalised medicine approaches.

The proposals may include a broad range of solutions, such as computational disease models, computational systems medicine approaches, machine-learning algorithms, Virtual Physiological Human, digital twin technologies and/or their combinations, as relevant. The topic covers different stages in the continuum of the innovation path (i.e. translational, pre-clinical, clinical research, validation in the clinical and real-world setting, etc.), as relevant to the objectives of the proposals.

The topic will support the development of the computational models driven by the end users’ needs.

Proposals should address several of the following areas:

  • Establish interdisciplinary research by bridging disciplines and technologies (disease biology, clinical research, data science, -omics tools, computational and mathematical modelling of diseases, advanced statistical and/or AI/machine learning methods, Virtual Physiological Human and/or digital twin technologies).
  • Develop new computational models for the integration of complex health data from multiples sources, including structured and unstructured data.
  • Develop and optimise robust, transparent and accurate computational models to guide patient stratification strategies for improving clinical outcomes.
  • Demonstrate, test and clinically validate such models with respect to their utility to realistically stratify patients with the aim of improving the standard-of-care.
  • The development of new patient stratification strategies guided by computational models and the validation of the new concepts of stratification in pre-clinical and/or clinical studies.

The proposals should adhere to the FAIR data principles, adopt data quality standards, data integration operating procedures and GDPR-compliant data sharing/access good practices developed by the European research infrastructures, wherever relevant. In addition, proposals are encouraged to adopt good practices of international standards used in the development of computational models, and make available the tools and solutions developed early. Proposals aiming to develop computational models of high technology readiness level are encouraged to deliver a plan for the regulatory acceptability of their technologies. Early interaction with the relevant regulatory bodies is recommended (i.e. the EMA qualification advice for new technologies, etc.) for the proposals contributing to the development of new medicinal products, improvement of the effectiveness of marketed products and the development of medical devices. The proposals aiming to validate their models as high-risk medical devices in the relevant clinical environment are encouraged to deliver a certification implementation plan.

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, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover 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. In addition, the proposals will be encouraged to exchange with other successful proposals developing AI algorithms and in silico models under other relevant topics.

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ENER/D3/2022-402

SAMIRA Study on Reporting and Learning from Patient-related Incidents and Near Misses in Radiotherapy, Interventional Cardiology, Nuclear Medicine and Diagnostic Radiology

Indicative budget: € 250000
Opening: 3 June 2022
Deadline(s): 15 September 2022

Keywords: radiotherapy; cardiology; nuclear medicine; diagnostic radiology 

Expected Outcome

This study aims to improve the reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology. In order to achieve this objective, the study hereby procured will:

  •  Collect and analyse up-to-date information on the implementation of Council Directive 2013/59/Euratom requirements for reporting and learning from patient related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology.
  • Develop best-practice guidance on the implementation of the above requirements in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology.
  • Discuss the results of the work with representatives of Member States and stakeholders, with the view of stimulating further national and EU-level efforts in this area.

Scope

The contractor will establish an advisory board that will provide its views on the methodology and results of the work at each step of the project. This board will include representatives of EU Member States regulatory, professional, patient and industrial stakeholders (which are not part of the project consortium), as well as relevant international organisations and bodies from non-EU countries. Tenderers shall propose the composition of the advisory board and the schedule of its involvement in the various tasks as part of their offers.

In order to avoid duplication of work and ensure co-ordination with other actions, the contractor will, during the implementation of the contract, regularly present project activities and results to the Steering Group on Quality and Safety of medical applications (SGQS) and to the Working Party on Medical Exposures (WP MED) of the Group of Experts established under Article 31 of the Euratom Treaty. The Commission may also request from the contractor to present the study to other relevant groups and initiatives.

Task 1: Survey on the implementation of the European legal requirements on reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology

Task 2: General and practice-specific guidelines on reporting and learning from patientrelated incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology

Task 3: Carry out consultations and agree on consensus European guidelines

Task 4: Project workshop

Further information on the tender is available here.

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ENER/D3/2022-105

Review and Analysis of the Transposition and Implementation of the Basic Safety Standards Provisions on Radiation Protection Expert (RPE), Radiation Protection Officer (RPO)

Indicative budget: € 250000
Opening: 3 June 2022
Deadline(s): 31 August 2022

Keywords: review; assess; radiation protection; medical physics

Expected Outcome

The objective of this study is to review and assess in detail the transposition and implementation of the requirements for Radiation Protection Experts (RPE), Radiation Protection Officers (RPO) and Medical Physics Experts (MPE) of the BSS Directive (Council Directive 2013/59), in the EU-27 Member States and in the United Kingdom, Norway and Switzerland. This study is intended to be an essential part of the transposition and conformity checks. It shall have a particular focus on the practical implementation of the Articles providing for the definition, roles and responsibilities, as well as education, training, and retraining of RPE, RPO and MPE as well as the detailed arrangements for their recognition.

This study shall assist the Commission in assessing compliance of the practical implementation of the legislative and administrative provisions for Radiation Protection Experts (RPE), Radiation Protection Officers (RPO) and Medical Physics Experts (MPE) in the EU Member States, with the requirements of the BSS Directive.

Scope

The specific objectives of this study are:

  • Review and detailed analysis of national legislative frameworks for RPE, RPO, and MPE as established by all EU Member States, the United Kingdom, Norway and Switzerland according to the requirements laid down in the BSS Directive
  • Review and detailed analysis of the practical implementation of the national frameworks including arrangements, structures and programmes for education, training, retraining and recognition of RPE, RPO and MPEs.
  • Preparation of a publishable report summarising the detailed findings of the study and recommendations.
  • Organisation of a workshop to enable discussion and exchange of experience among the EU Member States, the United Kingdom, Norway and Switzerland, European and international bodies and stakeholders.

Task 1: List of competent and national authorities and review with detailed analysis of the practical implementation of the national frameworks including arrangements, structures and programmes for education, training, retraining and recognition of RPE, RPO and MPEs.

Task 2: Review and detailed analysis of national legislative frameworks for RPE, RPO, and MPE as established by all EU Member States, the United Kingdom, Norway and Switzerland according to the requirements laid down in the BSS Directive

Task 3. Preparation of a publishable report on the results of the study

Task 4: Project workshop

Further information on the tender is available here.

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