Upcoming and open funding calls

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

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

The full text for Innovative Health Initiative call 6 and 7 may be found here. EU4Health calls may be found in full here.

Calls for Funding 

HORIZON-HLTH-2024-DISEASE-13-01

Implementation research for management of multiple long-term conditions in the context of non-communicable diseases (Global Alliance for Chronic Diseases – GACD)

Indicative budget: € 3-4 million
Opening: 25 April 2024
Deadline(s): 26 November 2024

Keywords: health interventions, quality of life, disadvantaged populations, chronic disease, health policy

Expected Outcome

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

  • Health care practitioners and providers in low- and middle-income countries (LMICs) and/or those in high-income countries (HICs) serving disadvantaged populations have access to and use specific guidelines to implement health interventions that improve  the availability of effective, equitable, efficient, integrated, patient-centred, safe, and timely care and the overall quality of life for people living with multiple long-term conditions including non-communicable diseases (NCDs).
  • Public health managers and authorities, including from other relevant sector (e.g., social, culture) have access to improved insights and evidence on how to decrease the fragmentation of care for patients living with multiple chronic conditions, and ensure continuity of care across all stages of disease progression. They use this knowledge to design policies to reduce health inequities.
  • Adopting an implementation science approach to studying interventions for management of long-term conditions in the context of NCDs, researchers, clinicians and authorities have an improved understanding how the proposed interventions could be adopted in LMICs and/or disadvantaged populations of HICs setting, taking into account specific social, political, economic and cultural contexts.
  • Communities and local stakeholders and authorities are fully engaged in implementing and taking up interventions for management of multiple long-term conditions in the context of NCDs and thus contribute to deliver better health.

Scope

The European Commission is a member of the Global Alliance for Chronic Diseases (GACD), an alliance of international funding agencies representing over 80% of the world’s public health research funding and the first collaboration of its kind to specifically address NCDs. The GACD supports implementation science to improve health outcomes. This topic is launched in concertation with the other GACD members and aligned with the 9th GACD call.

The topic is focused on implementation research for management of multiple long-term conditions in the context of NCDs (MLTC NCD) in LMICs and/or disadvantaged populations in HICs. Proposals should focus on implementation science around interventions that will generate evidence about when, for whom, and under what circumstances, patient-centred approaches can improve integrated care for patients with MLTC NCD.

MLTC NCD refers to the co-occurrence of multiple chronic conditions, at least one of which is an NCD. NCDs include for example cardiovascular diseases, chronic respiratory diseases, cancers, musculoskeletal disorders, diabetes, hypertension, haematological disorders, sleep disorders, and mental health disorders. The high prevalence of MLTC NCD is projected to rise with the ageing population and the increasing burden of NCDs. MLTC NCD has a profound impact on patients, and is associated with premature death, physical disability, substance abuse, poor quality of life, mental health issues, and financial difficulties from high costs of care. It is also associated with difficulties in adherence to and high rates of adverse effects from treatment with multiple medications. In addition, due to poor health and the complexity of managing their conditions, patients with MLTC NCD are high utilisers of health care systems, which is especially challenging in low-resourced contexts.

Addressing MLTC NCD demands a shift from fragmented models of care, which treat individual health issues separately as they occur, to a more holistic integrated care model that provides a whole person focus on health management. The current evidence suggests that primary healthcare, integrated and coordinated care, patient-centred interventions, digital health technology, and optimised medication therapy are key to improved management of MLTC NCD. However, implementing patient-centred strategies for treating MLTC NCD remains challenging and largely unexplored in disadvantaged contexts, especially in LMICs. Adapting and scaling such models is critical to improving quality of life; reducing disability; reducing the burden of caretaking on (typically female) family members and reducing health system costs.

The proposed implementation research must focus on one or more evidence-based interventions (or complex interventions) known to promote integrated management of multiple long-term conditions, including NCDs. It should assess patient-centred interventions focused on patient management or self-management, or interventions that transform communities, clinical practice, and/or health systems. Applicants should justify the choice of intervention(s) and provide evidence of the intervention’s effectiveness, acceptability, feasibility, and potential for long-term health and other impacts. Ideally, evidence of the intervention’s real-world effectiveness should be supported by a well-conducted systematic review where available. As the evidence for how to manage MLTC NCD is still emerging, particularly in LMICs, a limited period of testing the effectiveness of an intervention that the applicant’s team has adapted for local implementation is therefore usually appropriate.

Applicants must explore the implementation of proposed intervention(s) for a selected study population(s) taking into account the unique social, political, economic, and cultural context(s) in which the study will take place. Applicants should justify why any adaptation
will not compromise the known effectiveness of the selected intervention(s).

Proposals should address all of the following activities:

  • Provide a research plan using validated implementation research frameworks or hybrid design research;
  • Have an appropriate strategy for measuring implementation research outcomes and real-world effectiveness outcomes and indicators;
  • Specifically address health equity and the principles of Universal Health Coverage; In keeping with the principles of Universal Health Coverage, the World Health Organization advocates that health systems move towards offering a continuum of quality NCD preventative, diagnostic, curative, rehabilitative, and palliative care services, that are available and accessible to all, independent of economic circumstances.
  • Engage an appropriately expert and skilled research team which can ensure a suitable multidisciplinary approach and that demonstrates equitable partnership and shared leadership between HIC-LMIC, and/or non-Indigenous–Indigenous members of the project team and external stakeholders through a clear governance strategy;
  • Provide a stakeholder engagement strategy with evidence of support/engagement from key stakeholders for delivering patient-centred care and a pathway to sustain the proposed intervention after the funding ends;
  • Provide opportunities for implementation research capacity building for early career researchers and team members from lower resourced environments, such as LMICs or disadvantaged communities.
  • Ensure meaningful involvement of early career team members, including at least one early career member as a co-investigator.

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HORIZON-MISS-2024-CANCER-01-01

Use cases for the UNCAN.eu research data platform

Indicative budget: € 30 million
Opening: 18 April 2024
Deadline(s): 18 September 2024

Keywords: uncan.eu platform, EU Cancer Mission, use cases, data analysis tools, FAIR data

Expected Outcome

The aim of this topic is to operationalise the UNCAN.eu research data platform foreseen in the Cancer Mission implementation plan, through a series of use-cases. To this goal, proposals are expected to develop tools supporting researchers to access, manage and analyse cancer digital data, building among others on resources developed by EOSC4cancer.

Proposal(s) under this topic are expected to contribute to all of the following outcomes:

  • The UNCAN.eu platform is developed by federating a network of cancer data nodes built on European and national computing infrastructures that link different cancer data holders across European countries.
  • Use-cases focusing on the understanding of cancer initiation and progression are designed and implemented by multidisciplinary teams to develop tools and services for working with FAIR data.
  • Researchers and clinicians use the electronic resources provided by the UNCAN.eu platform to access, manage and analyse data of heterogeneous types and belonging to different research domains at an unprecedented scale.

Scope

The successful proposal should:

  • Develop the UNCAN.eu platform by integrating and, where relevant, complementing existing or planned data nodes of European research infrastructures or other national infrastructures that may link various cancer data holders across Member States and Associated Countries (e.g., hospitals, research centres, comprehensive cancer centres, etc.). The number of Member States involved should be sufficient to demonstrate scalability and flexibility of the UNCAN.eu platform while allowing for stepwise onboarding of more countries.
  • Provide tools, services and workflows to researchers across data nodes for dataset creation, standardisation, data discovery, secure access, management, visualization, harmonization, analysis and other functions as appropriate. This task should capitalise on EOSC4cancer’s achievements, integrating and expanding as appropriate the available tools and solutions. It should also take advantage of the European Health Data Space and the European Open Science Cloud frameworks.
  • Design and implement a rich and diverse portfolio of use-cases to inform, steer the development and demonstrate the validity of the UNCAN.eu platform. Use cases should focus on research questions that are in line with the Cancer Mission objectives and that may advance the understanding of mechanisms involved in cancer development and progression beyond the current state of the art. At least one use-case should target a cancer type with a 5-year overall survival of less than 50% from the time of diagnosis. A second use-case should target paediatric cancer.
  • At the same time, use-cases should be functional to the design and implementation of UNCAN.eu to increase the diversity of digital tools and services available for cancer researchers. The mobilisation and integration of a large amount of research and real word data beyond current practice and a balanced participation of clinicians, disease experts and data scientists will be essential to achieve the objectives of this topic. Due attention should be paid to sex and gender, disaggregating the data as appropriate.
  • The successful consortium should develop innovative approaches, to integrate and analyse heterogeneous data from multiple sources and different research domains, including the participation of the necessary interdisciplinary set of European infrastructures and national data nodes. In this regard, at least one use-case should integrate imaging, digital pathology and genomic data, using and/or contributing with new data sources to the Genomics Data Infrastructure (GDI) and Cancer Image Europe (EUCAIM).
  • Give emphasis to data being managed and shared in line with the FAIR principles, and the concept of FAIR-by-design is applied wherever possible. The applicants must demonstrate that the necessary data sources are, or will be, effectively and timely available. During the project lifetime, new data sources that might become available at a later stage can be accommodated as well as allowing additional data holders to join the UNCAN.eu platform. Results must be open source and made available through a public repository under a permissive license. Open access data should be provided whenever possible.
  • Give due consideration to, and establish appropriate links with, EU-funded initiatives such as EHDS-related governance and implementation actions, the European Network of Cancer Registries.
  • Foresee to establish links with the successful proposal resulting from the topic HORIZON-MISS-2024-CANCER-01-02 ‘Support dialogue towards the development of national cancer data nodes.’

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

The Commission will facilitate coordination. Therefore, proposals should include a budget for networking, attendance at meetings, and potential joint activities without the prerequisite to give details of these at this stage. Examples are organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate.

Successful proposal will be asked to join the ‘Understanding’ cluster for the Mission on Cancer established in 2022. The details of joint activities will be defined during the grant agreement preparation phase and during the life of the project.

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HORIZON-MISS-2024-CANCER-01-02

Support dialogue towards the development of national cancer data nodes

Indicative budget: € 3 million
Opening: 18 April 2024
Deadline(s): 18 September

Keywords: national cancer data nodes, European Health Data Space, EU Cancer Mission, platform integration

Expected Outcome

Data is an essential resource to improve our understanding of cancer, advance prevention and early detection strategies, facilitate the delivery of personalised care, and better address the quality of life of cancer patients and survivors.

The Cancer Mission supports the creation of the European Initiative to Understand Cancer (UNCAN.eu, a federated European cancer research data infrastructure) and the European Cancer Patient Digital Centre (ECPDC, a European network of national digital infrastructures for cancer patients).

The proposal under this topic is expected to contribute to all of the following outcomes:

  • Advance the process of establishing National cancer data nodes, by the scaling-up or improvement of existing national health data infrastructures and by fostering their links to the European Health Data Space infrastructures for primary and secondary data uses.
  • Potential barriers that may prevent the effective implementation of UNCAN.eu and ECPDC digital platforms are identified and a way forward to address them proposed.

Scope

The proposal should address all of the following:

  • Foster the development of national cancer data nodes through policy dialogues at national level with relevant actors in the research and innovation community, digital health and public health policy.
  • Identify and build synergies between European infrastructures related to health data access and health data sharing for primary and secondary data uses (e.g., MyData@eu, HealthData@eu, ELIXIR, BBMRI, and others), and other initiatives relevant for the UNCAN.eu and ECPDC platforms.
  • Identify challenges and barriers to the effective future implementation of the UNCAN.eu and the ECPDC platforms at national and European levels and propose operational solutions to overcome them.
  • Identify population subgroups with poor digital skills and geographical areas with limited digital resources that might prevent the use of those platforms and propose solutions to reduce the digital divide.

The involvement of cancer research centres, digital infrastructures, public health bodies, policy makers and cancer patient organisations will ensure that the UNCAN.eu and ECPDC platforms will deliver effective outcomes for researchers, clinicians, healthcare providers, cancer patients, survivors, and caregivers.

Due consideration should be given to EU-funded initiatives, infrastructures and projects such as: EOSC4cancercanSERV, the European Cancer Information System, and the successful proposals resulting from the topics; HORIZON-MISS-2024-CANCER-01-01, HORIZON-MISS-2024-CANCER-01-06.

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, to produce meaningful and significant effects enhancing the societal impact of the related research activities.

The Commission will facilitate coordination. Therefore, successful proposals should include a budget for networking, attendance at meetings, and potential joint activities without the prerequisite to give details of these at this stage. Examples are: organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Successful proposals will be asked to join the ‘Understanding’ and ‘Quality of Life’ clusters for the Mission on Cancer established in 2022 and 2023. The details of joint activities will be defined during the grant agreement preparation phase and during the life of the project.

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HORIZON-MISS-2024-CANCER-01-03

Accessible and affordable tests to advance early detection of heritable cancers in European regions

Indicative budget: € 35 million
Opening: 18 April 2024
Deadline(s): 18 September 2024

Keywords: regional cancer incidence, early detection and diagnosis tests, accessiblity and affordability, heritable risk, national/regional authorities

Expected Outcome

For an increasing number of cancers with underlying heritable genetic risk, early detection and diagnosis are possible. Moreover, cancer incidence and mortality across Europe are increasing and show substantial variation, with Central and Eastern European regions and countries particularly affected. Decisive action on early detection using easy-to-use, specific and sensitive, affordable and accessible genetic multi-omics or other biomarker-based tests will contribute to diagnosing and treating cancer with an underlying heritable genetic risk at an earlier, potentially curable stage, and with fewer side-effects.

Proposals should aim to deliver results through validating, piloting, and upscaling genetic, multi-omics, or other biomarker-based tests for early detection of cancers with underlying heritable genetic risk in routine healthcare, which are directed and tailored towards and contribute to all of the following expected outcomes:

  • People and their families at heritable genetic risk of developing cancer, will benefit from the outcomes of evidence-based, tailored, affordable and accessible early detection, based on accessible and affordable tests;
  • Civil society, foundations, and innovators will seize opportunities to respectively co-create, support or commercialise early detection programmes based on genetic, multi-omics or other biomarker-based tests.
  • Regional and national policymakers and authorities in Member States and Associated Countries will engage in piloting, scaling up or implementing suitable early detection and treatment of people and their families with underlying heritable genetic risk in European regions based on genetic, multi-omics or other biomarker-based accessible and affordable tests, including legislative policies.

Scope

There is a need to validate, pilot, and upscale easy-to-use genetic, multi-omics or other biomarker-based tests for early detection of cancers with an underlying heritable genetic risk, for uptake in regional or national healthcare systems. Proposals should address all of the following:

  • Validate easy-to-use, affordable and accessible genetic, multi-omics or other biomarker-based cancer tests for early detection of cancers with an underlying heritable genetic risk for uptake in regional or national healthcare systems. Validation may include for example clinical studies, socio-economic or technological feasibility studies.
  • Stratify the to-be-tested population by sex, gender, age or other determinants.
  • Be compliant with GDPR and take into account socio-economic status, limited health literacy, limited awareness of disease symptoms and access for people in remote and rural areas.
  • Tests can be based on, for example, polygenic cancer risk scores, algorithms, machine learning, biomarkers, cell lines, organoids, liquid biopsies, medical devices, or wearables and other digital applications.
  • Co-create with end-users, including (citizens, and health professionals, such as psychologists) living in the targeted regions, aspects such as the innovation life cycle, priority definition, design, development, testing and piloting stages as well as risk assessment, counselling, health education, and acceptability.
  • Extensively pilot and upscale genetic, multi-omics or other biomarker-based testing for use in early detection programmes in at least three regions across at least three different Member States or Associated Countries. One of the three targeted regions should be within the following Member States: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia or Slovenia.
  • Preferably work together with one of the EIT-Health KIC networks to establish appropriate contacts, and support relevant entrepreneurship, education, training, capacity building or innovation aspects for interested stakeholders in the targeted regions.

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.

Successful results are expected to be communicated to the Knowledge Centre on Cancer (KCC) to foster their uptake within the EU.

The Commission will facilitate coordination. Therefore, successful proposals will be asked to join the ‘Prevention and Early Detection’ cluster for the Mission on Cancer established in 2022 and should include a budget for networking, attendance at meetings, and potential joint activities without the prerequisite to give details of these at this stage. Examples are: organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. The details of joint activities will be defined during the grant agreement preparation phase and during the life of the project.

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HORIZON-MISS-2024-CANCER-01-05

Improving the understanding and management of late-effects in adolescents and young adults (AYA) with cancer

Indicative budget: € 36 million
Opening: 18 April 2024
Deadline(s): 18 September 2024

Keywords: AYA cancer survivors, cancer data, late effects, regional disparities, quality of life

Expected Outcome

Proposals under this topic should aim to deliver results that are directed and tailored towards and contribute to the following expected outcomes:

  • Increased awareness and improved understanding of the incidence, severity, and impact of late effects in AYA cancer survivors among healthcare providers, patients, caregivers and the general public;
  • Researchers, innovators, and professionals from different disciplines and sectors ensure accessibility and re-usability of their data, models, tools and technology to support the UNCAN.eu platform, which is currently in preparation;
  • Identification of effective interventions and best practices to support AYA patients and survivors in preventing, reducing and better managing late-effects, promoting optimal health outcomes and overcoming disparities between regions;
  • Improved quality of life and long-term outcomes for AYA cancer survivors, including improved physical, emotional, and social well-being.

Scope

This topic will contribute to the achievement of the Mission’s objective to improve the quality of life of cancer patients, survivors and their families. The focus should be exclusively on adolescent and young adult (AYA, age range 15-39) cancer patients and survivors.

Each year, more than 150,000 AYA cancers are diagnosed in the EU, and over 1.2 million worldwide. About 300,000 AYA patients live with or beyond cancer in the EU; the majority experience late-effects due to their cancer treatment, including chronic pain, cardiovascular disease, organ and skin alterations, cosmetic sequelae, fertility problems, cognitive and functional impairment, and mental health issues such as depression and anxiety. Survivors may also be at increased risk of second cancers due to the long-term effects of radiation and chemotherapy. The negative impact on education and employment of AYA survivors and in general the financial burden borne by them is also commonly observed.

Late effects are particularly challenging for AYA cancer survivors, who often experience them during a critical phase of their lives. Late effects are also challenging for caregivers. The considerable progress made in treating AYA cancers has further exposed gaps in the understanding, prevention and management of late-effects, which warrant more targeted pan-European research on AYA cancer survivorship.

Proposals should focus on one or more cancer types and address only one of the following interventions:

  • Building on data from existing or newly established AYA patient cohorts, ensuring comparability of data across participating countries as appropriate, obtain a thorough assessment by cancer type of the prevalence, specific effect(s), severity, time of onset, relative risk, and risk factors associated to late effects in AYA cancer patients. Attention should be paid also to social and health determinants, including sex, gender, age and other relevant variables, including socio-economic status, living in rural or remote areas and education;
  • Develop, test and scale-up evidence-based screening methods for the early detection of late-effects in AYA cancer patients;
  • Develop, test and scale up in real-life settings, innovative, holistic approaches and tools (including digital tools), optimising cancer treatment and follow-up regimens to prevent, reduce and/or effectively manage late-effects, including psycho-social aspects. Approaches could focus on education, sports, nutrition, medical follow-up and counselling, for example on mental and physical health, pain management, and wellbeing in general, as well as reproductive matters, including infertility, onco-fertility and fertility options in general and development of effective methods for fertility preservation and guidelines on related counselling.

This topic requires direct involvement of cancer patients and survivors, survivor representative organisations, caregivers, and the effective contribution of 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 results, enhancing the impact of the related research activities.

The use of participative research models, such as oncology-centred living labs or other approaches to deliver (social) innovation should be considered.

Due consideration should be given to EU-funded initiatives such as: EU-CAYAS-NETERN PaedCan, PanCareFollowUpPanCareSurPass, EUonQoL, e-Quol, and STRONG-AYA.

The Commission will facilitate coordination. Therefore, successful proposals will be asked to join the ‘Quality of Life’ cluster for the Mission on Cancer established in 2023 and should include a budget for networking, attendance at meetings, and potential joint activities without the prerequisite to give details of these at this stage. Examples: organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. The details of joint activities will be defined during the grant agreement preparation phase and during the life of the project.

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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

Indicative budget: € 6.5 million
Opening: TBD
Deadline(s): TBD

Keywords: guideline and quality assurance scheme, cancer prevention, cancer screening

Expected Outcome

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.

Scope

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.

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CR-g-24-42

Call for proposals on radiation safety and quality of computed tomography imaging of children, adolescents and young adults

Indicative budget: € 3 million
Opening: 17 September 2024
Deadline(s): 22 January 2025

Keywords: Radiation safety, imaging, nuclear medicine

Expected Outcome

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.

Scope

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.

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CR-g-24-37

Call for proposals to support integration of cancer images into the federated pan-European infrastructure to foster screening programmes

Indicative budget: € 8 million
Opening: 18 June 2024
Deadline(s): 10 October 2024

Keywords: cancer imaging data

Expected Outcome

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.

Scope

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.

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HORIZON-JU-IHI-2024-06-01-two-stage

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

Expected Outcome

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.

Scope

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) [1], 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.

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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

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

Expected Outcome

  • 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.

Scope

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).

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HORIZON-JU-IHI-2024-07-01-singe-stage

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

Expected Outcome

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.

Scope

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.

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HORIZON-JU-IHI-2024-07-03-singe-stage

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

Expected Outcome

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

Scope

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;

and/or

  • 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.

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CR-p-23-41

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

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

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

Scope

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

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

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CR-p-23-44-02

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

Indicative budget: € 300,000
Opening: Q4 2023
Deadline(s): TBD

Keywords: medical devices; radiation protection; legal implementation 

Scope

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

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