Upcoming and open funding callsWe'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.
A confidential copy of the draft 2023-2024 Horizon Europe Health work programme and the draft 2023-2024 Cancer Mission calls is available at the EIBIR office. Members are invited to get in touch for more information.
Calls for Funding
- CR-g-24-37: Call for proposals to support integration of cancer images into the federated pan-European infrastructure to foster screening programmes
- CR-g-24-42: Call for proposals on radiation safety and quality of computed tomography imaging of children, adolescents and young adults
- CR-p-24-38: Development of European guidelines and quality assurance scheme for gastric cancer prevention and care and preparing the third report on the status of implementation of the Council Recommendations on cancer screening
- HORIZON-JU-IHI-2024-06-01-two-stage: Support healthcare system resilience through a focus on persistency in the treatment of chronic diseases
- HORIZON-JU-IHI-2024-06-02-two-stage: Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence
- HORIZON-JU-IHI-2024-07-01-single-stage: Improving clinical management of heart disease from early detection to treatment
- HORIZON-JU-IHI-2024-07-03-singe-stage: Clinical validation of biomarkers for diagnosis, monitoring disease progression and treatment response
- HORIZON-HLTH-2024-STAYHLTH-01-05-two-stage: Personalised prevention of noncommunicable diseases – addressing areas of unmet needs using multiple data sources
- HORIZON-HLTH-2024-TOOL-05-06-two-stage: Innovative non-animal human-based tools and strategies for biomedical research
- IHI-04-01: Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical drug safety assessment
- IHI-04-02: Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare
- IHI-05-02: Development and proof of principle of new clinical applications of theranostics solutions
- IHI-05-03: Improved prediction, detection, and treatment approaches for comprehensive stroke management
- IHI-05-04: Maximising the potential of synthetic data generation in healthcare applications
- 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)
- CR-p-23-41: Development of EU guidelines and quality assurance scheme for lung, prostate and gastric cancer screening
- 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
Call for proposals to support integration of cancer images into the federated pan-European infrastructure to foster screening programmes
Indicative budget: € 8 million
Keywords: cancer imaging data
The action will support hospitals and other imaging repositories, for example those involved in conducting cancer screening, in creating enabling conditions for becoming a node in the European federated infrastructure of cancer imaging data. Short-term improvements include strengthening the collaboration between national and regional screening programmes for breast, lung and prostate cancers, with the European Cancer Imaging Infrastructure in particular regarding the management of the screening data and opportunistic screening (as opposed to organised, population-based screening programmes) and with the relevant infrastructures of the proposed European Health Data Space, such as HealthData@EU. The project beneficiaries are expected to represent a wide range of relevant stakeholders such as researchers, NGOs, experts, Member States institutions and industry.In the mid-term, this action is expected to increase the geographical reach of the European Cancer Imaging Initiative. It will also contribute to the alignment of the European Cancer Imaging Infrastructure with the proposed EHDS infrastructures and processes. Close collaboration of projects participants is expected with the European Cancer Imaging Initiative, in particular the EUCAIM project, and with relevant stakeholders involved in the implementation of the proposed EHDS regulatory framework. Links should be established with EU4Health actions on screening, Comprehensive Cancer Centres in Member States and other relevant actions under the Europe’s Beating Cancer Plan and Cancer Mission, as well as with other relevant actions concerning the proposed EHDS. The action shall contribute to other relevant actions under the Europe’s Beating Cancer Plan and the Cancer Mission.
The action will provide enabling support for cancer imaging data providers, to contribute to and benefit from the European Cancer Imaging Initiative. The action will improve readiness of national, regional or local imaging data repositories to connect and make available their data via the European infrastructure of cancer images data established under the DIGITAL programme (EUCAIM project) and to use this infrastructure for data enrichment and insights by accessing the nodes, tools and methodologies offered by EUCAIM. This action is relevant for the proposed European Health Data Space. In order to contribute to the planned EHDS, this action will seek alignment with the relevant EHDS infrastructures (MyHealth@EU and HealthData@EU). Where applicable, it will link cancer imaging databases with the relevant bodies and infrastructures in the proposed EHDS, particularly health data access bodies and HealthData@EU. This action will also explore ways to leverage on the EHDS interoperability specifications for the European Electronic Health Record exchange Format, including relevant eHealth Network guidelines, as well as minimum specifications for datasets to be used for research and innovation.
Call for proposals on radiation safety and quality of computed tomography imaging of children, adolescents and young adults
Indicative budget: € 3 million
Keywords: Radiation safety, imaging, nuclear medicine
As an expected outcome of the activities and in line with the SAMIRA objective to ensure that applications of ionising radiation in Member States operate in line with high standards for quality and safety, medical staff should have improved tools to ensure justification and optimisation of medical procedures involving ionising radiation in children and young adults. This should take various forms of technical/practical tools, like improved imaging referral and clinical guidelines, guidance, protocols and tools for specific exams and equipment, education and training curricula and material. Trainings for the hospital staff and information campaigns should also be organised. This will benefit paediatric, adolescents, and young adult patients, and parents and young adults accessing imaging services in Member States. The actions are expected to bring short-term improvements in radiation safety and quality of CT imaging in children and young patients and reduction of avoidable exposure to ionising radiation. In the mid- to long- term, this is expected to translate into reduced avoidable secondary effects, such as brain cancer linked to head CT exams.The outcomes of these activities should also reduce discrepancies in Europe to current radiation technology in medical applications through a coordinated approach.
The aim of the action is to enhance the quality and radiation safety of medical applications of ionising radiation in children, adolescents and young adults. Actions taken should in particular focus on computed tomography procedures in children and young adults and aim to reduce the associated risk of adverse secondary effects, such as brain and other types of cancer.
This action should cover in priority head CT exams in children, adolescents and young adults. It can be extended to other body regions, as well as other imaging modalities involving ionising radiation, if there is a frequent clinical indication for paediatric imaging and improved justification and optimisation is considered achievable. This action could include conventional and interventional radiology, CT and nuclear medicine and could also include imaging procedures performed as part of radiotherapy treatments.
The activities carried out in this action should include the following:
a) review of referral guidelines for imaging, clinical guidelines, and clinical decision support systems in use in Member States for justification of head CT in children, adolescents and young adults and recommendations for improvement of these guidelines to the relevant actors;
b) review of the equipment base and the access to dedicated paediatric imaging in Member States for head imaging in children, adolescents and young adults and recommendations for improvement of the equipment base to the relevant actors;
c) development of guidance, protocols and tools for optimisation of paediatric head CT exams, for the CT devices and the clinical indications that are the most used in Europe;
d) the organisation of information and dissemination campaigns concerning recommendations, guidance, protocols and tools for justification and optimisation of paediatric imaging among the concerned hospitals and medical centres in all Member States;
e) development of education and training curricula, material, and tools on radiation protection of paediatric CT patients, for the applicable professional groups;
f) the organisation of a training of radiologists, radiographers, medical physicists, and radiology nurses in practical approaches to radiation protection of paediatric CT patients;
g) the organisation of information campaigns about the benefits, risks and radiation safety of CT imaging in paediatric, adolescent and young adult patients, targeted at parents and young adults.
Development of European guidelines and quality assurance scheme for gastric cancer prevention and care and preparing the third report on the status of implementation of the Council Recommendations on cancer screening
Indicative budget: € 6.5 million
Keywords: guideline and quality assurance scheme, cancer prevention, cancer screening
The expected results are the following:
On gastric cancer prevention and care:
a) an established Working Group (expert panel) and conflict of interest assessments;
b) final results of the epidemiological analysis;
c) scoping of the development of the Commission’s initiative on gastric cancer;
d) development of risk assessment-model for gastric cancer guidelines;
e) mapping of healthcare questions, available requirements and indicators on gastric cancer care;
f) systematic reviews and evidence to decision frameworks;
g) risk-based gastric cancer guidelines for primary prevention, screening and diagnosis;
h) requirements and indicators covering the entire care pathway;
i) quality assurance scheme manual that defines the accredited certification process in line with EC Regulation 765/2008 and the service requirements and indicators.
All outcomes will be published on the Commission’s web hub hosted at the JRC for European guidelines and European quality assurance schemes within the context of organised and population-based screening programmes. This action will result in ‘European guidelines for gastric cancer prevention, screening and diagnosis’ and a ‘European quality assurance scheme for gastric cancer prevention, screening and care’ to support Member States to further design, plan, and implement population-based and targeted gastric cancer screenings and diagnosis where applicable.
As regards the cancer screening report:
a) an established Working Group (panel of experts from different countries having access to cancer screening data) and conflict of interest assessments;
b) Working Group members trained to be able to apply the data tools available through ECIS platform for data collection and submission;
c) the collection and validation of information and data from different Member States and associated countries to report status, organisation and performance of screening programmes for breast, cervical, colorectal and lung cancer screening;
d) collaboration with ongoing projects of the Commission established to collect information and data from the pilot prostate and gastric cancer screening programmes;
e) collaboration with ongoing projects of the Commission established to develop indicators and data collection tools for risk-based approach to cancer screening and data collected from any such pilots;
f) the 3rd report on the implementation of Council recommendation of 9 December 2022 on strengthening prevention through early detection: A new EU approach on cancer screening replacing Council Recommendation 2003/878/EC prepared to include status,
organisation and performance of breast, cervical, colorectal, lung, prostate and gastric cancer screening in the EU/EEA and associated countries;
g) status of utilization of quality assurance scheme and the certification process is included in the report.
The objectives and activities will cover:
On gastric cancer prevention and care:
The overall aim is the development of evidence-based European guidelines, and a quality assurance schemes for particular consideration by those Member States with highest gastric cancer incidence and death rates allowing for a step-wise and gradual roll-out. The methodology developed in previous initiatives such as the Commission Initiative on Breast Cancer and on Colorectal Cancer should be applied. Preliminary analysis should be conducted on the epidemiological situation in Member States (and potentially also associated countries) to pursue a risk-based screening approach across the Union for the definition of the overall scope (e.g.,
indications of pathologies and targeted population) for the Commission Initiative on Gastric cancer.
On the cancer screening report:
The overall aim is the preparation of the 3rd Report on the Implementation of the Council Recommendation on cancer screening including to educate and guide the cancer screening programme managers to collect and submit cancer screening performance data using the new data collection tools to be able to estimate the new set of performance indicators. The project will target EU/EEA countries and associated countries to support collection of high-quality data across the cancer screening continuum for ongoing programme monitoring and quality improvement.
Support healthcare system resilience through a focus on persistency in the treatment of chronic diseases
Indicative budget: € 13.3 million
Opening: 16 January 2024
Deadline(s): 16 April 2024 (first stage), 10 October 2024 (second stage)
Keywords: chronic disease, health technology, treatment regimen, guidelines and recommendations
The main outcome of this research collaboration is to better understand why significant advances in technology in recent years have not contributed to widespread improvements in healthcare systems, which still struggle to keep more than 50 % of people on chronic disease treatment for longer than 12 months. The goal is to develop and pilot innovative and multi-stakeholder approaches leveraging social innovation activities and scalable technology to improve the health outcomes of people living with chronic diseases by supporting treatment persistency with a particular focus on diabetes, obesity, and cardiovascular disease. Persistency is part of drug adherence and is defined as the length of time between starting treatment and the last dose which immediately precedes discontinuation of medication.
Although novel treatments are becoming more available with major improvements in convenience and efficacy, poor persistency to treatment is still a major challenge in the healthcare system. Insights from pilots under this topic will be shared with relevant stakeholders of the healthcare ecosystem to improve outcomes for people living with chronic diseases. The pilots should include cardiometabolic diseases, such as diabetes, obesity, and cardiovascular disease. Other chronic diseases may be considered in this collaboration if they contribute to the overall understanding of barriers and opportunities. Moreover, it is not the goal to develop new technologies and/or pharmaceutical drugs during the course of the project, but rather to address how insights and new approaches can be applied in clinical practice and implemented in guidelines and recommendations.
The action under this topic must contribute to all of the following outcomes:
- Map and share insights from existing projects, pilots and datasets to get to a shared understanding of what the barriers and opportunities in the respective healthcare systems are in order to improve persistency and health outcomes for people living with chronic diseases;
- Develop and implement new/revised collaborative models between public and private organisations with the aim of improving persistency and health outcomes;
- Generate clinical and scientific evidence to demonstrate results in order to show the value of these new approaches and technologies;
- Integrate new insights into the treatment regimen in close collaboration with people living with chronic diseases to improve disease outcomes;
- Develop a consistent methodology/framework for measuring persistency using real-world data;
- Develop recommendations and consensus reports with relevant healthcare stakeholders;
- Optimise communication between healthcare systems and patients to improve persistency.
The scope of this topic is to improve treatment persistency among people living with chronic diseases. According to the MEDI-VOICE project funded by the European Commission, non-adherence to medication accounted for approximately 200 000 deaths annually in the European Union, and according to a World Health Organisation (WHO) report from 2003, around 50 % of people living with a chronic disease do not adhere to the prescribed medication. From a recent analysis by Kvarnström et al (2018) , the major barriers for adherence to medication range from a lack of disease knowledge by the patient to logistical barriers like availability of medication and price (see list below), ultimately leading to discontinuation of medication.
The major categories of barriers identified are:
- Patient specific, e.g. lack of knowledge, lack of routines, poor health literacy, gender, transition from paediatric to adult care, socioeconomic background;
- Disease specific, e.g. lack of symptoms, lack of improvement, illness fatigue;
- Treatment specific, e.g. side effects, complexity in dosages, inconvenience;
- Healthcare and system specific, e.g., poor communication among stakeholders including e.g. physicians, patients, pharmacies, insurance providers, service providers, policy makers;
- Social and culture specific, e.g. stigmas, religious belief, other alternatives;
- Logistic and finance specific, e.g., price, renewal of prescription.
To address these barriers, this topic is expected to focus on the healthcare- and system-specific categories. The barriers to persistency identified in the list above are strongly interlinked, and in an effort to better understand the healthcare ecosystem in relation to persistency, it is the goal to especially explore the interface between the patient and healthcare providers. It is well-described that a lack of timely and accurate interaction/communication between patient and healthcare provider is key. Patients may lack education about their disease(s) and when support is minimal and there is insufficient patient counselling available, it can leave the patient with unanswered questions which might lead to discontinuation of their medication. In addition, social components, in particular health equalities including stigma and financial barriers, will also be in focus.
In this topic we propose a strong public-private coalition to help define and drive new models for collaboration across the healthcare ecosystem to improve persistency. This is to the benefit of patients as well as healthcare system sustainability by leveraging scalable technology that may hold the key to improving healthcare at the same time as providing it to many more individuals projected to have chronic diseases. A key component to successful implementation will be the patient voice and user experience.
It is planned to:
- Share experiences and insights from existing pilots in specific healthcare environments and disease areas;
- Use both observational and diverse clinical research methodologies to demonstrate impact, including health economics and outcomes research;
- Drive fit-for-purpose studies to secure the evidence needed to maximise impact – particularly moving from test to scale;
- Foster close collaboration between industry and academia within this field to ensure fast and feasible execution in real-world settings;
- Build internal understanding & competencies within persistency to inform drug, study and service development;
- Build training programmes for healthcare stakeholders;
- Analyse how the new learnings/insights might be implemented in clinical treatment guidelines.
Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence
Indicative budget: € 13.3 million
Opening: 16 January 2024
Deadline(s): 16 April 2024 (first stage), 10 October 2024 (second stage)
Keywords: real-world data, guidance and recommendations, health technology assessment, innovative medicines and health technologies, drug-device combinations
- Industry, sponsors, and other stakeholders have access to structured, evidence-based and practical guidance and recommendations on the use of real-world data / real world evidence (RWD/RWE) that could be followed to support the development, and regulatory, health technologies assessment (HTA), and payer decision-making of innovative medicines and health technologies with a focus on medicinal products, medical devices, and therapeutic products that combine a medicinal product with a medical device (drug-device combinations).
- Regulators, HTA bodies and payers will receive more structured and consistent RWD/RWE submissions to inform their decision making.
The use of real-world evidence to support decision making on the safety of medicinal products is already well established. More recently, RWE has also been used to complement evidence and support marketing authorisation, conformity assessments and HTA submissions. While high-level guidance on the use of RWD/RWE exists, the practical implementation is left up to individual sponsors. Currently, RWD/RWE submissions are usually custom-made to a specific use-case and require significant expertise and effort from the sponsor to prepare, and from the healthcare decision-maker to assess. Much knowledge exists within individual sponsors on these use-cases, but, to date, this has not been leveraged to develop practical guidance which could act as a baseline for future submissions.
To leverage the learning from individual use cases and facilitate the efficient use of RWD/RWE for regulatory, HTA, and payer submissions and to inform healthcare decision-making, structured, evidence-based, and practical guidance is needed.
To address this challenge, the action funded under this topic should:
- Map relevant RWD/RWE initiatives across Europe and their (expected) outcomes. Where relevant, build on, align, and complement these initiatives, including the European Medicines Agency’s vision to establish the value of RWE across the spectrum of regulatory use cases by 2025.
- Identify the main challenges faced by industry, sponsors, non-commercial sponsors, health professionals, prescribers, and other stakeholders in the routine use of RWD/RWE for regulatory and HTA decision-making. This is to be done by also taking into account the differences in the regulatory frameworks of medicinal products and medical devices and how stakeholders’ experiences, needs, and situations are reflected in these.
- In collaboration with the relevant stakeholders, identify, review, and evaluate existing methodologies, guidelines, and practices for the use of RWD/RWE in healthcare decision-making.
- Focus on an in-depth study of a broad range of use cases where RWD/RWE has been previously assessed for decision-making for medicinal products, medical devices, and combinations. This should include an analysis of methods, designs, and defining variables that enable the grouping and thereafter the utilisation of RWD/RWE sources. Particular attention should be paid to the features that enable efficient assessments.
- Using the results of the study as a foundation, develop a draft of the practical guidance document and recommendations on the use of RWD/RWE to support submissions and decision-making processes, taking into consideration the specific needs of medicinal products and medical devices. Considerations on how RWD/RWE can be used within an ethical framework and respects EU values should be included. In addition, ensure that the guidance respects the EU data quality framework and the relevant RWD specialisation (which is currently under development).
- Test the draft guidance in several pilots to ensure validity and broad acceptability. The precise scope of these pilots should be selected by the full consortium during preparation of the full proposal and should address multiple contexts and areas that are not already being addressed, including but not limited to: chronic serious diseases, oncology, and auto-immune diseases. They should also cover clinical development and the regulatory, HTA, and payer assessment of medicinal products and medical devices including combinations.
- Based on the learnings from the pilots, finalise the practical guidance document and recommendations on the use of RWD/RWE to support clinical development, regulatory, HTA and payer submissions and inform decision-making processes.
- Broadly disseminate the guidance and recommendations to the stakeholder community. Create training plans to enable dissemination.
Applicants should develop a strategy and plan for generating appropriate evidence as well as for engaging and formally consulting with regulators, HTA agencies and payers in a timely manner, in particular on the draft guidance (e.g., through national competent authorities, the EMA Innovation Task Force, qualification advice).
In addition, while the project will focus on supporting the development of a recommendation for a structured, practical and evidence-based guidance, the funded project is also expected to explore synergies with complementary initiatives to advance RWD/RWD in Europe such as the GetReal Institute, REDDIE, More-EUROPA, Oncovalue, Real4Reg, RWE4Decisions, TEHDAS, QUANTUM, CORE MD, REALM and projects under the ongoing call for proposals HORIZON-HLTH-2024-IND-06-08. It should also be aligned with the ambitions and guidelines set out for the European Health Data Space (EHDS).
Improving clinical management of heart disease from early detection to treatment
Indicative budget: € 10-15 million
Opening: 16 January 2024
Deadline(s): 22 May 2024
Keywords: heart disease; clinical management; integrated solutions; care pathway; innovative technologies; improved procedures, programs and workflows
Actions under this topic must contribute to all the following outcomes, ultimately contributing to reducing the burden of heart disease:
- Healthcare systems and patients benefit from the development of integrated solutions for improving critical aspects in the overall care pathway (primary, ambulatory and hospital care) for heart disease.
- Healthcare systems and patients will benefit from the development or optimisation of innovative technologies leading to personalised, patient-centric solutions for the early detection, diagnosis or treatment of heart disease.
- Patients benefit from proposed strategies tailored to their needs for improved outcomes in heart disease.
- Healthcare professionals benefit from the deployment of solutions for improved diagnostic procedures, referral programs or clinical workflows as well as targeted training for relevant clinical staff where appropriate.
Heart disease includes structural heart disease (SHD), coronary artery disease (CAD), heart failure (HF) and heart arrythmias, which are common, devastating, and heterogeneous medical conditions causing a high burden in Europe and worldwide.
It is estimated that SHD affects 14 million people in Europe alone, while, worldwide, HF affects more than 64 million, atrial fibrillation more than 37 million and 244.1 million people were living with CAD in 2020. The impact of these diseases is significant both in terms of the health-related quality of life of patients and caregivers, and the large economic burden, amounting to over EUR 280 billion in the EU for cardiovascular disease (CVD). In Europe, the prevalence of these conditions is expected to rise due to the ageing population and the lifestyle of citizens and, thus, the economic burden will also increase dramatically in the next decades with the costs for health care accounting for the largest part.
However, despite the importance of SHD, CAD, HF and heart arrythmias, disease management and long-term outcomes remain heterogeneous due to the lack of comprehensive access to detection, diagnosis and care. The care of people with heart disease is also highly complex, with a multitude of diagnostic procedures and multidisciplinary therapeutic approaches available, including pharmaceutical, minimally-invasive and surgical interventions, disease-modifying therapies, and cardiac rehabilitation. Moreover, means for early diagnosis are often suboptimal, thus novel approaches should be explored to provide sustainable and scalable solutions.
Critically, improved early detection, diagnosis, referral and patient stratification linked to optimised clinical workflows and clinical decision-making hold the promise of faster, personalised treatments. However, to achieve their successful implementation, there is a need for substantial cross-sectorial research and innovation and better integration of the different steps of care from primary to hospital care for an optimised disease management in more efficient healthcare settings.
Projects funded under this topic should address all or any of the following heart diseases: SHD, CAD, HF, and heart arrythmias.
Applicants are expected to assemble a suitable cross-sectoral public-private partnership to propose activities to address the following objectives in heart disease. In this context, applicants may consider identifying and addressing only some critical aspects of the patients’ journey or specific care settings, with the aim of contributing to the overall care pathway improvement.
- Improve the efficiency of primary care, ambulatory or hospital care, considering how to optimise the patient pathway from one to the other and the transition among the teams in each care setting.
- Improve patient outcomes through earlier detection, better diagnosis, monitoring and/or treatment. This may include the development or deployment of innovative technologies or package solutions for early detection and diagnosis, or to seamlessly both treat and monitor (e.g., personalised imaging technologies, personalised sensing technologies, artificial intelligence (AI) powered clinical decision tools, digital imaging, diagnostic technologies).
- Develop and implement measures and digital tools to enhance efficiency and optimise patient outcomes in primary and hospital care (e.g., reducing hospitalisations, disease burden and/or length of stay), and ensure a continuum between early detection, diagnostic and therapeutic approaches by guiding patients faster to the selection of the best treatment modality. This could be done for example via procedural automation, non-invasive testing, improved access to data, integrated pathways dashboards, and AI-powered clinical decision making.
- Develop personalised, patient-centric solutions in diagnosis and treatment to improve patients’ healthcare experience, considering the needs of specific populations such as children, elderly patients, cardio-oncology patients, or patients with co-morbidities.
- Adequate consideration should be given to the sustainability and scalability of the proposed solutions.
- Explore management strategies combining access to medical teams specialising in heart disease and social interventions to address population inequalities in outcomes. Also consider the heterogeneity of the healthcare system in Europe and generate evidence applicable across the diversity of European realities.
- Conduct an initial health economic study (such as cost-effectiveness analyses, budget impact models, etc.) of the proposed interventions on the healthcare system. The health economic study could include, for example, an analysis on whether an optimised management of heart diseases results in avoiding or reducing hospital treatment and the related costs.
- Patients and healthcare professionals should be engaged in all stages of the project from conceptualisation and throughout the implementation (e.g., in raising public awareness, education of patients, helping with the improvement of the referral pathway and the pathway to treatment, developing targeted training for relevant clinical staff).
- Consider the potential regulatory impact of the results and as relevant develop a regulatory strategy and interaction plan for generating appropriate evidence as well as engaging with regulators in a timely manner (e.g. national competent authorities, the European Medicines Agency (EMA) Innovation Task Force, qualification advice).
Applicants should also reserve resources to synergise with other relevant initiatives, including other projects funded under this topic and those resulting from IHI call 2 topic 1 (iCARE4CVD) and IHI call 5 topic 3, as well as with other European research initiatives and infrastructures, such as the European Partnership on Transforming Health and Care Systems (THCS), the Healthier together – EU non communicable diseases (NCD) initiative, and the European Partnership for Personalised Medicine (EP PerMed) among others.
Clinical validation of biomarkers for diagnosis, monitoring disease progression and treatment response
Indicative budget: € 10-15 million
Opening: 16 January 2024
Deadline(s): 22 May 2024
Keywords: biomarkers, clinical validation, disease diagnosis and monitoring, treatment optimisation and response, linked technologies, regulatory acceptance
Actions under this topic must contribute to all the following expected outcomes:
- Access for healthcare professionals to novel, robust and fit for purpose biomarkers with linked technologies enabling their use in clinical setting and progress towards validation. Biomarkers and linked technologies may be for diagnosis, monitoring disease progression, selecting the optimal therapeutic treatments, or assessing treatment response.
- Availability for researchers of robust and fit-for-purpose biomarkers with linked technologies enabling their clinical use for diagnosing disease, disease monitoring, or monitoring treatment response. This will enable researchers to develop safer and more effective personalised treatments tailored to the individual’s characteristics and the stage of their disease. Alternatively, availability for researchers of key technology (e.g. companion diagnostics) that could be essential for the safe and appropriate use and selection of a corresponding drug or biological product or its development.
- Availability for regulators of robust evidence on the suitability of selected biomarkers and their linked technologies to enable regulatory acceptance for a specific use
Biomarker-driven approaches for diagnosis, monitoring disease progression and assessing treatment response have immense potential to help us progress precision medicine. Despite intense research, few biomarkers are subject to rigorous testing in clinical settings and shown to be fit for purpose (clinically validated). In addition, while there are several novel biomarkers that have shown significant promise for a number of use cases, often the technology to make them accessible for clinical use is not mature enough, which hampers their validation for use. Thus, technology development or improvements to existing technologies may be required to progress these biomarkers to clinical validation. For example, there are many novel and highly innovative technologies in development (e.g. imaging, artificial intelligence (AI), omics markers, phage-based diagnostics in multiple formats among others) and their further development and validation would be a necessary element for validating their detected biomarkers in the clinic.
Furthermore, different healthcare actors (e.g. academics, clinicians, patients, health technology developers and regulators) may have different definitions and expectations on the utilities of biomarkers, and there is a need for an aligned methodological framework for scaling up the clinical validation of candidate biomarkers.
To address this challenge, this topic aims:
- To progress candidate biomarkers towards clinical validation and, when relevant, to regulatory acceptance;
- To progress towards clinical validation innovative technologies necessary for making biomarker(s) accessible for clinical use. In proposals focusing uniquely on these technologies, applicants should justify how such progress will enable the validation of the biomarker(s) for use in a clinical context.
Projects funded under this topic should:
- Assemble a cross-sectoral public-private partnership to align and develop a methodological framework and roadmap for progressing selected candidate biomarker(s) and/or linked technologies enabling the clinical use of the biomarker(s) (or a combination thereof) to rigorous clinical validation
- Provide a justification and clearly demonstrate why the proposal area responds to an unmet public health need.
- Progress biomarker(s) and/or technologies towards clinical and analytical validation in one or more of these areas: diagnosing disease, early treatment path selection, monitoring disease progression, or treatment response assessment:
- All types of biomarkers including digital, combinations of biomarkers and multimodal biomarkers are in scope. Proposals addressing biomarker(s) intended for specific populations such as the elderly or children are very welcome.
- The candidate biomarkers can be combined with existing biomarkers for more personalised decision making.
- All types of technologies for progressing biomarkers to a stage closer to clinical validation, including innovative and novel approaches, are in scope. Some examples could be technologies for the effective collection, preparation, measurement and analysis of samples and biomarkers, or diagnostic equipment, methods, or systems.
- In their proposal, applicants must clearly identify the candidate biomarker(s) and/or linked technology(ies) and the proposed application in research and development (R&D) and/or clinical practice.
- Applicants should provide in their proposal sufficient preliminary evidence, including relevant methodology(ies) and high quality data to demonstrate that the biomarker(s) and/or technology(ies) can be progressed towards clinical validation and, when relevant, to regulatory acceptance.
- As relevant, applicants must ensure effective collection, preparation, measurement, and analysis of biomarker samples to allow validation in the clinical setting.
- Build on existing solutions to develop a collaborative platform to integrate, analyse and share data (historical or generated de novo) gathered for the validation of biomarker(s) and/or linked technologies during the project, as well as to support future biomarker validation beyond the project duration. Applicants should plan to ensure the future scalability and sustainability of the platform and future data sharing and ensure adherence to FAIR (findable, accessible, interoperable, reusable) principles.
- Develop a regulatory strategy and interaction plan for evidence generation to support the regulatory qualification of the biomarker/s and/or technologies and engage with regulators in a timely manner (e.g., national competent authorities, European Medicines Agency (EMA) Innovation Task Force, qualification advice). Applicants should reserve resources to support these interactions.
- Elaborate a plan for interacting with all the relevant actors in the learning healthcare system (for example clinicians, academic researchers, healthcare professionals, health technology developers, regulators, policy makers, and others as relevant) to align on utilities of the candidate biomarker(s) and/or technologies for clinical use and guide the roadmap.
- Disseminate the results of the project to ensure uptake by relevant stakeholders, including healthcare systems and technology developers.
- Applicants should also reserve resources to synergise with other relevant initiatives, including other projects funded under this topic and those funded under IHI Call 3 topic 1 as relevant.
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
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.
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.
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
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.
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.
Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical drug safety assessment
Indicative budget: € 4.5 million
Opening: 27 July 2023
Deadline(s): 8 November 2023 (first stage), 23 April 2024 (second stage)
Keywords: non-human primates; new research pathways; non-invasive digital technologies; non-animal models; knowledge sharing
- 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.
- Increasing need to find alternatives to testing in NHPs in line with EU legislation;
- 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 scientific knowledge to scientifically justify a de-selection of NHPs in the non-clinical safety assessment of new therapeutics. 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.
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.
- Compile and publish existing historical safety data in minipig biomedical R&D and discuss data with regulators;
- Evaluate the translatability of minipigs in human risk assessment following treatment with biologicals and new therapeutic modalities, and discuss future perspectives of the minipigs with regulatory agencies, e.g., by requesting regulatory interactions with European Medicines Agency (EMA) such as scientific advice and/or novel methodology qualification advice to understand possible regulatory hurdles in using minipigs for safety assessment;
- Minipigs multi-omics: Generate omics reference data (genomics, transcriptomics, proteomics, metabolomics, and epigenetic information) to enable translational research in minipigs. To further characterise the minipig, imaging technologies such as magnetic resonance imaging (MRI), computed tomography (CT) scans and positron emission tomography (PET) scans are also of interest;
- 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 non-clinical 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.
Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare
Indicative budget: € 4.5 million
Opening: 27 July 2023
Deadline(s): 8 November 2023 (first stage), 23 April 2024 (second stage)
Keywords: obesity, biological pathways and pre-obesity markers, environmental, socio-economic and lifestyle factors, prevention, evidence-based guidelines, recommendations
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 utilise 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. The harmonisation will critically enhance the implementation of microsampling in global clinical trials of new therapeutics. The validation and establishment of microsampling at home by patients and/or their caregivers 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.
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). To assure patient-centricity, feedback on the umbrella protocol by patient representatives and caregivers will be sought. The umbrella / master protocol must include:
- Sites in at least 3 EU member states, and may include additional sites (with at least one in Eastern Europe) in third countries associated or not associated to Horizon Europe;
- At least two different types (e.g., finger stick, upper arm capillary) of commercially available CE-marked microsampling devices. For clarity, at least one device should perform liquid blood sampling; the additional devices may collect dried blood;
- Routine clinical assays: i.e., blood chemistry, liver and lipid panels;
- Collection of at least 50% of microsamples by the patient or caretaker; the other 50% may be taken by hospital or nursing personnel (including remote nurses, e.g., in general practices, or traveling nurses);
- Collection of least 50% of microsamples at home. The project 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, obtain competent/regulatory authority 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 the support need for the use of devices and training 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;
- If possible, to assess the cost savings obtained with microsampling methods as compared to gathering blood in the hospital.
3. Education and Medical & Patient Acceptability
- To deliver training materials for patients, caregivers and clinical trial sites, taking into account the variety of patients’ and caregivers’ ages, abilities, etc., and ensuring smooth behind-the-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 get insights into research questions related to the implementation of microsampling which are described in the expected outcomes above.
- 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, other non-EU European countries and the US
- 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, and to conduct an in-depth exploration in those countries that might be suitable for the microsampling logistics modelling;
- To establish an early and continuous dialogue with the European Medicine Agency (EMA) Innovation Task Force, in addition to local regulatory agencies of the EU, and relevant authorities of other non-EU European countries and the FDA:
- To assess acceptability with regulators and seek prospective input on the umbrella / master protocol, choice of countries and approach to validating 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, guidance document) to share project results, request scientific and qualification advice, and seek a harmonisation with the regulatory agencies from other non-EU European countries and the FDA, which is key to global clinical trials of new therapeutics.
- To interact with policy makers, HTA experts, payers, and advocacy groups to facilitate the implementation of project results in clinical practice throughout the EU, and other non-EU European countries and the US.
Development and proof of principle of new clinical applications of theranostics solutions
Indicative budget: € 10–12 million
Opening: 27 July 2023
Deadline: 16 January 2024
Keywords: theranostics; non‑nuclear approaches; multi-modal solutions; clinical trials; novel tools; Europe’s Beating Cancer Plan
Research and innovation (R&I) actions to be supported under this topic must contribute to at least three of the following outcomes:
- Patients will benefit from increased treatment efficacy, reduction of time-to-treat, fewer side effects, and reduced duration of hospitalisation.
- Healthcare professionals benefit from education, training on theranostic treatment approaches, recommendations, and clinical guidelines on the most appropriate use of theranostic solutions.
- European healthcare systems benefit from a broader spectrum of theranostic treatments and improved cost-effectiveness and affordability of theranostic solutions due to scale effects and more robust European supply chains.
- Technology developers, healthcare professionals and patients benefit from increased information on the sensitivity, quantification, stratification and staging of diseases
Multi-modal theranostic solutions, currently dominated by radionuclide-based therapy and companion diagnostics, are emerging as safe, personalised, and effective approaches for the treatment of several diseases. However, the use of such therapies is limited to a few specialised centres with the need to increase clinical treatment capacities, and to widen the arsenal of theranostics, possibly including novel non‑nuclear approaches, e.g. enabled by nanotechnologies.
To address this challenge, project(s) funded under this topic should aim at developing new, or innovative combinations of existing multi-modal theranostic solutions including radiopharmaceuticals and/or non- radioactive theranostic solutions. Applicants should clearly identify a disease(s) of unmet public health need, (e.g., oncology, neurology and/or advanced multi-disease conditions) and explain their choice with relevant evidence where possible.
In particular, for the selected disease(s), the project(s) funded under this topic are expected to address all the following objectives:
- Develop innovative theranostic solutions and consider conducting early phase clinical trial(s) as proof of concept(s) to demonstrate the added value of the proposed theranostic solutions for patients;
- Ddevelop tools for the quantification of the chosen disease(s) through the development of novel modalities to ensure proper planning and monitoring of patient care, which may include imaging, artificial intelligence and pathology models;
- Facilitate the development of tools to increase European theranostic manufacturing capabilities and treatment capacities, including guidance on quality assurance and improving logistics of supply at the EU level;
- Develop education and training materials on the deployment of multi-modal theranostic solutions and their integration in clinical settings including recommendations for the organisation and composition of disease-specific medical expert boards
In addition, applicants are expected to consider the potential regulatory impact of the results and if relevant develop a strategy/plan for generating appropriate evidence as well as engaging with regulators in a timely manner (e.g., through the EMA Innovation Task Force, qualification/scientific advice).
Improved prediction, detection, and treatment approaches for comprehensive stroke management
Indicative budget: € 10–12 million
Opening: 27 July 2023
Deadline: 16 January 2024
Keywords: stroke pathways; integrated data; decision support; personalisation of care; modelling tools
Research and innovation (R&I) actions (projects) to be supported under this topic must aim to deliver results that contribute to all the following expected outcomes.
- Patients will benefit from superior healthcare compared to the current standard of care through the availability of a clear pathway for prevention, diagnosis, and treatment of their stroke. This should be achieved by early and rapid diagnosis of stroke, more integrated and precise interventions, and treatment strategies with the patient in the centre.
- Healthcare professionals will have access to integrated patients’ health data, improved visualisation, predictive computational models and clinical support decision systems for stroke, and benefit from efficient coordination among and within stages of care and clinical specialities.
- Healthcare systems will benefit from more effective organisation of stroke management and personalisation of care delivery. This will increase treatment and care effectiveness and efficiency.
- Researchers will benefit from access to integrated data, innovative modelling-based tools, and a more patient-centred definition of clinical outcomes after stroke (including patient reported outcome measurement and patient reported experience measurement), which will facilitate the continued improvement and development of future intervention strategies.
- Health care systems, researchers, and industry will benefit from new innovative modelling tools enabling integration and analysis of a wider, actionable range of patient-specific data, including federated analysis of data.
Globally, stroke is the second leading cause of death and the third leading cause of disability. One in four people are in danger of stroke in their lifetime.
In Europe in 2017, nearly 1.5 million people suffered a stroke, nine million Europeans lived with a stroke, and more than 430,000 people died due to a stroke. The total cost of stroke in that year was €60 billion. The number of new strokes and the number of people living with stroke is set to rise due to the ageing population of Europe, as age is the greatest, non-modifiable risk factor for stroke.
Stroke is a heterogeneous, multifactorial disease regulated by non-modifiable (e.g., age, sex, family history) and modifiable risk factors (e.g., high density lipid-cholesterol, low density lipid-cholesterol, cigarette smoking) and underlying pathologies (such as diabetes, hypertension, atrial fibrillation) and as such, it requires a multi-factorial approach. However, stroke is a preventable, treatable, and manageable disease and thus the potential to reduce its burden and its long-term consequences exists.
The challenge in stroke management is the lack of efficient and comprehensive pathways along the whole continuum of the disease – including the variation of structural settings depending on the location of the patient (rural vs. central) and between countries. While several effective treatment approaches are available, there are still silos existing between the different stages of care (e.g., primary, acute care, intensive care, chronic hospitalisation, rehabilitation). The implementation of connected healthcare pathways will lead to an improvement in the outcome for the patients and thereby drive efficiency and effectiveness from a clinical and health resource perspective.
Better communication, sharing and integration of data along the whole stroke care pathway has the potential to be a game changer for stroke patients and for the healthcare professionals as well as payers.
Integrating data is key to allow for modelling, artificial intelligence (AI) and machine learning (ML)-based evaluation to identify groups and individual persons at risk and assure early recognition of stroke, thereby providing faster diagnosis and optimal, patient-specific treatment, resulting in better outcomes for patients. Effective, personalised and rapid care is critical and can make a substantial difference between full recovery and possible permanent impairment or death.
Moreover, comprehensive stroke management continues in the post-acute treatment setting and includes long-term follow-up for secondary prevention and rehabilitation. This is important, as a high percentage of patients are readmitted to the hospital or suffer a second stroke. More than a quarter of patients do not adhere to medication and/or have their blood pressure controlled. Patients frequently report that post-stroke follow up is impaired by siloed data between their generalist and specialist care.
Innovative solutions for faster acquisition, integration, and better retention of multiple types of data and better organisation among the various actors across the entire stroke pathway are crucial to achieve optimal prevention and treatment focused on the needs of patients. Use of novel technologies for federated data analytics and interpretation could help in this direction and assist in providing the right treatment to patients in a timely manner, improving their outcomes.
Applicants to this topic should address all the aims below in their proposals.
- Develop approaches to integrate patient-relevant health data, from primary care/outpatient clinic, hospital, and rehabilitation settings, as relevant, improving data retention along the care pathway. Applicants could consider starting with a focus on patients at higher risk with the possibility to expand to other patients
- Develop a next generation of systems that promote interoperability of data from different settings (including intensive and acute care units) and support better clinical decision making. Strategic approaches for integration with the EHDS and community-based, collaborative integrated care should be considered
- Create solutions to foster better access to data for all involved healthcare professionals (primary care, hospital care and after hospital release e.g., rehabilitation) and support exchange of knowledge and information between the different actors – including at the level of algorithms and datasets that can be exchanged under ethically and legally sound conditions
- Develop innovative tools and approaches, for example ‘virtual human twin’ model approaches and AI/ML for enhanced computational modelling, optimised for transparency to users and non-users, federated data analytics, and visualisation for enhanced output/results view and interpretation. These tools aim at appropriate risk stratification, timely prediction of stroke and stroke recurrence, faster diagnosis, and treatment
- Propose innovative approaches to improve and expedite diagnostic and treatment decisions for streamlining operations and guiding patients in the continuum of stroke care in a patient-centric way. This should include consideration of the complexity of the organisational dimension
- Propose approaches to improve implementation and scale-up of treatment in Europe relying on multimodal clinical data capture and their better interpretation and use in patient management and clinical decision-making. This should include consideration of the regional differences in stroke management and access to treatment options across Europe
- Propose approaches to enhance precision of care delivery as well as improving patient experience and quality of life using new technologies, tools, and educational means (e.g., education on identification of risk factors, signs of stroke, treatment adherence)
Maximising the potential of synthetic data generation in healthcare applications
Indicative budget: € 10–12 million
Opening: 27 July 2023
Deadline: 16 January 2024
Keywords: synthetic data generation; open-source data; AI- and data-driven diagnostics; personalised health; intellectual property; European Health Data Space
The proposals should contribute to all of the following expected outcomes:
- Academic and industrial researchers should have access to relevant, robust, and generalisable synthetic data generation methodologies, including open source when relevant, to create and share pools of synthetic patient data in specific use cases;
- Academic and industrial researchers should have access to relevant, high quality synthetic datasets;
- Thanks to better availability of robust synthetic datasets for training data models, healthcare providers and industry should have a wider range of performant AI-based and other data-driven tools to support diagnostics, personalised treatment decision-making and prediction of health outcomes.
Healthcare research using individual patient data is often constrained due to restrictions in data access because of privacy, security, intellectual property (IP) and other concerns. Synthetic health data, i.e., data that is artificially created to mimic individual patient data, can reduce these concerns, leading to more rapid development of reliable data-driven methods including diagnostic, precision medicine, decision support and patient monitoring tools. However, while many synthetic data generation (SDG) methods are currently available, it is not always clear which method is best for which use case, and SDG methods for some types of data are still immature. Furthermore, it is still unclear whether highly detailed synthetic data, which are often needed for research, can be categorised as anonymous.
To address these challenges and maximise the opportunity offered by synthetic data, projects funded under this topic should address the following objectives:
- Assemble a cross-sectoral public-private consortium including synthetic data experts, public and private data owners, and healthcare solution developers;
- Using high-quality public and private datasets, develop / further develop and validate reliable SDG methods for relevant healthcare use cases. The use cases to be explored must be described and justified in the proposal, complement work that is already ongoing, and should:
- Ensure the broad applicability of the SDG methods developed and include data types that are not currently adequately addressed, such as device data, image data, genomic data etc;
- Include methods to generate: a) fully synthetic datasets that do not contain any real data; b) hybrid datasets composed of a combination of data derived from both real and synthetic data; and c) synthetically-augmented datasets.
- Pay particular attention to bias, both in source data and in the SDG methods.
- Validate the synthetic data generation methods applied in the project using source data. This should include assessing the risk of re-identification;
- Demonstrate the quality and applicability of the synthetic data generated in the project through the development of relevant models;
- Encourage the uptake of the results of the project through a strong communication and outreach plan
Applicants are expected to consider allocating appropriate resources to explore synergies with other relevant initiatives and projects, including the EC proposal for an European Health Data Space (EHDS) when it becomes operational.
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
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.
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.
Development of EU guidelines and quality assurance scheme for lung, prostate and gastric cancer screening
Indicative budget: € 7.5 million
Keywords: cancer screening; lung, prostate, gastric cancer; quality assurance; health guidelines
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.
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: Q4 2023
Keywords: medical devices; radiation protection; legal implementation
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.