Pandemic preparedness and response: Sustaining established coordination mechanisms for European adaptive platform trials and/or for cohort networks
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-HLTH-2023-DISEASE-03-05
- Programme
- Tackling diseases (Single stage - 2023)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- January 12, 2023
- Deadline
- April 13, 2023
- Deadline Model
- single-stage
- Budget
- €20,000,000
- Min Grant Amount
- €7,000,000
- Max Grant Amount
- €8,000,000
- Expected Number of Grants
- 3
- Keywords
- HORIZON-HLTH-2023-DISEASE-03-05HORIZON-HLTH-2023-DISEASE-03Clinical trialsCohort studiesDisease controlEmergent diseasesEmerging EpidemicsEpidemiologyHealth sciencesInfectious diseasesPublic and environmental healthPublic health and epidemiology
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:
- The research community sustains appropriate coordination mechanisms 1) among different EU-wide adaptive platform trials and/or 2) among established cohorts in Europe and beyond with a view for better pandemic preparedness and response,
- The adaptive platform trial and/or the cohort networks maximise coordination and harmonisation of their respective studies within their relevant network for maximum research efficiency and optimal evidence generation.
- The European adaptive platform trial and/or the cohort networks coordinate with the European Pandemic Preparedness Partnership, and are well connected to each other and to relevant other regional and global initiatives.
The COVID-19 pandemic research response has illustrated the importance of clinical research preparedness, as well as the benefit gained from the coordination between European clinical research initiatives. Two key pillars of such clinical research in pandemic preparedness and response are the clinical (interventional) trials and the cohort (observational) studies.
The large-scale European COVID-19 clinical trials have been gathered under a network for COVID-19 therapeutic trials[1] and a network for COVID-19 vaccine trials[2] and strong common coordination mechanisms between the trials have been established. The recently launched Ecraid[3] is a European clinical research network that has been in development since before the COVID-19 pandemic. The EU-funded projects conducting cohort research in Europe and globally have also come together to establish stronger coordination between them.
This topic aims at maintaining and strengthening existing strategic coordination mechanisms across adaptive platform trials and across cohort studies in Europe and beyond for avoiding redundancies, promoting complementarities and facilitating cooperation among EU-funded clinical research for infectious diseases. Proposals should strengthen the leading role of the EU in clinical research preparedness for future epidemics and pandemics, through ensuring coordination of the European adaptive platform trials and of the European cohort studies. The coordination mechanisms support the longer-term perspective of preparedness for future infectious disease epidemics and pandemics, where the networks enable the conduct of perpetual platform trials and of perpetual strategic cohorts with the in-built agility to pivot to emerging diseases when an epidemic strikes.
Proposals should describe a coordination mechanism for adaptive platform trials and/or for cohort research. The coordination mechanism builds on existing coordination efforts for these networks, providing strategic support and vision for the perpetual trials and cohort studies belonging to the networks in the context of pandemic preparedness. Within the adaptive platform trial network, the coordination mechanism supports reflections e.g. on the diversity of the trial target populations (e.g. primary care or hospitalised patients) or on different possible medical countermeasures (e.g. therapeutics, vaccines), etc. Within the cohort network, the coordination mechanism supports reflections e.g. on diversity in type of cohorts and research questions to be addressed, or on harmonised approaches to data collection and analysis, etc.
Proposals should address proper connections with relevant European initiatives and organisations, such as the European Pandemic Preparedness Partnership, the European Health Preparedness and Emergency Response Authority (HERA), as well as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). Synergies with successful proposals under the HORIZON-INFRA-2023-DEV-01-01 topic should be sought, and collaboration with other relevant research infrastructures should be envisaged. Proposals should also be open to engage with global initiatives such as the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)[4], the Global Health EDCTP3 Joint Undertaking[5], or the World Health Organization (WHO).
Proposals should address the following areas:
- Fostering a trusted and proactive environment within the coordination mechanism that supports the timely exchange of research results, allows for discussion on challenges encountered in their research and finding solutions together to ensure cooperation and synergy within each network;
- Developing a common approach for the European clinical research to enable pragmatic solutions to shared challenges across European clinical trials and/or cohorts for pandemic preparedness and response, guaranteeing the best interest of European trial or study patients or volunteers;
- Promoting an optimal use of resources, based on a sound scientific approach and maximising the value added for the generation of scientific evidence, through a common baseline approach towards protocol development, harmonised and FAIR data[6] collection and analysis leveraging existing initiatives;
- Involving relevant European stakeholders, such as representatives from regulatory authorities, industry, policymakers, patient organisations, etc., as well as relevant non-European networks and stakeholders;
- Promoting the visibility and attractiveness of European adaptive platform trials and/or cohorts for clinical investigators in Europe and beyond ; as well as active communication with the science community, patient advocacy groups and other stakeholders, to develop trust, and also promote innovative approaches;
- Partners within the coordination mechanism should develop a plan to ensure its sustainability. Coordination with the European Pandemic Preparedness Partnership and the European Health Preparedness and Emergency Response Authority (HERA) is expected.
[1] https://covid19trials.eu/en
[6] See definition of FAIR data in the introduction to this work programme part.
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘Good health and high-quality accessible healthcare’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘health care providers are able to better tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) and reduce the disease burden on patients effectively thanks to better understanding and treatment of diseases, more effective and innovative health technologies, better ability and preparedness to manage epidemic outbreaks and improved patient safety’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A resilient EU prepared for emerging threats’, ‘Climate change mitigation and adaptation’, and ‘High quality digital services for all’.
Communicable and non-communicable diseases cause the greatest amounts of premature death and disability in the EU and worldwide. They pose a major health, societal and economic threat and burden. Many people are still suffering from these diseases and too often dying prematurely. Non-communicable diseases, including mental illnesses and neurodegenerative diseases, are responsible for up to 80% of EU health care costs[1]. These costs are spent on the treatment of such diseases that to a large extent are preventable. Furthermore, only around 3% of the health care budgets are currently spent on preventive measures although there is a huge potential for prevention. Infectious diseases, including emerging infectious diseases and infections resistant to antimicrobials, remain a major threat to public health in the EU but also to global health security. Deaths caused by antimicrobial resistance (AMR) could exceed 10 million per year worldwide according to some predictions[2].
To further advance, there is an urgent need for research and innovation to develop new preparedness and prevention measures, public health interventions, diagnostics, vaccines, therapies, alternatives to antimicrobials, as well as to improve existing preparedness and prevention strategies to create tangible impacts, taking into account sex/gender-related issues. This will require international cooperation to pool the best expertise and know-how available worldwide, to access world-class research infrastructures and to leverage critical scales of investments on priority needs through a better alignment with other funders of international cooperation in health research and innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases, to address antimicrobial resistances, to respond to major unmet medical needs for global health security, including the global burden of non-communicable diseases, and to strengthen patient safety.
In this work programme, destination 3 will focus on major societal challenges linked to the Commission’s political priorities such as the fight against cancer and other non-communicable diseases, better diagnosis and treatment of rare diseases, preparedness and response to and surveillance of health threats and epidemics, reduction of the number of antimicrobial-resistant infections, improving vaccination rates, demographic change, mental health and digital empowerment in health literacy. In particular, the topics under this destination will support activities aiming at: i) better understanding of diseases, their drivers and consequences, including pain and the causative links between health determinants and diseases, and better evidence-base for policymaking; ii) better methodologies and diagnostics that allow timely and accurate diagnosis, identification of personalised treatment options and assessment of health outcomes, including for patients with a rare disease; iii) development and validation of effective intervention for better surveillance, prevention, detection, treatment and crisis management of infectious disease threats; iv) innovative health technologies developed and tested in clinical practice, including personalised medicine approaches and use of digital tools to optimise clinical workflows; v) new and advanced therapies for non-communicable diseases, including rare diseases developed in particular for those without approved options, supported by strategies to make them affordable for the public payer; and vi) scientific evidence for improved/tailored policies and legal frameworks and to inform major policy initiatives at global level (e.g. WHO Framework Convention on Tobacco Control; UNEA Pollution Implementation Plan).
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 3 “Civil security for society” such as on health security/emergencies (preparedness and response, medical countermeasures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with cluster 4 “Digital, Industry and Space” such as on decision-support systems or on geo-observation and monitoring (e.g. of disease vectors, epidemics); or with cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on health security and AMR (one-health: human/animal/plant/soil/water health). In addition, while focusing on civilian applications, there may be there may be synergies with actions conducted under the European Defence Fund, notably in the field of defence medical countermeasures.
Based on needs that emerged during the management of COVID-19, some research and innovation actions under Destination 3 should support the mission of the European Health Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the availability and access to key medical countermeasures. Other actions should deliver relevant complementary inputs to the “Europe’s Beating Cancer Plan”[3] in order to cover the entire cancer care pathway, including prevention, early detection, diagnosis, treatment, cancer data monitoring, as well as quality of life of cancer patients and survivors. Furthermore, synergies and complementarities will be sought between Destination 3 and the implementation of the EU4Health Programme (2021-2027)[4]. These synergies and complementarities could be achieved, notably through mechanisms based on feedback loops, enabling on the one hand to identify policy needs that should be prioritised in research and innovation actions and facilitating on the other hand the implementation of research results into policy actions and clinical practice, thereby providing an integrated response across sectors and policy fields.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts:
- Health burden of diseases in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care. In particular, patients are diagnosed early and accurately and receive effective, cost-efficient and affordable treatment, including patients with a rare disease, due to effective translation of research results into new diagnostic tools and therapies.
- Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and well-being is promoted, and the voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (DALYs)[5],[6], [7].
- Health care systems benefit from strengthened research and innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. In particular, they are better prepared to respond rapidly and effectively to health emergencies and are able to prevent and manage communicable diseases transmissions epidemics, including within healthcare settings.
- Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[8], [9].
- Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).
The EU benefits from high visibility, leadership and standing in international fora on global health and global health security.
[1] Currently, around 50 million people in the EU are estimated to suffer from two or more chronic conditions, and most of these people are over 65. Every day, 22 500 people die in Europe from those diseases, counting of 87% of all deaths. They account for 550 000 premature deaths of people of working age with an estimated €115 billion economic loss per year (0.8% of GDP).
[2] AMR is estimated to be responsible for 25 000 deaths per year in the EU alone and 700 000 deaths per year globally. It has been estimated that AMR might cause more deaths than cancer by 2050.
[4] https://ec.europa.eu/health/funding/eu4health_en
[5] WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 (resolution WHA66.10), https://www.who.int/publications/i/item/9789241506236
[6] Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non-communicable diseases in both public and private facilities.
[7] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.
[8] WHO global action plan on antimicrobial resistance, 2015
[9] EU One Health Action Plan against AMR, 2017
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE CSA) - call-specific application form is available in the Submission System
Standard evaluation form (HE CSA)
HE General MGA v1.0
Information on clinical studies (HE)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
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Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
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The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
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Latest Updates
Call HORIZON-HLTH-2023-DISEASE-03
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 150
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 63
Total budget requested for above-threshold proposals: EUR 432,892,132.
Call HORIZON-HLTH-2023-DISEASE-03
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 150
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 63
Total budget requested for above-threshold proposals: EUR 432,892,132.
Call HORIZON-HLTH-2023-DISEASE-03 closed on 13 April 2023. 150 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2023-DISEASE-03-01: 29 proposals
- HORIZON-HLTH-2023-DISEASE-03-03: 21 proposals
- HORIZON-HLTH-2023-DISEASE-03-04: 27 proposals
- HORIZON-HLTH-2023-DISEASE-03-05: 4 proposals
- HORIZON-HLTH-2023-DISEASE-03-06: 1 proposals
- HORIZON-HLTH-2023-DISEASE-03-07: 46 proposals
- HORIZON-HLTH-2023-DISEASE-03-17: 13 proposals
- HORIZON-HLTH-2023-DISEASE-03-18: 9 proposals
Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.