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Call key data

Pandemic preparedness and response: Sustaining established coordination mechanisms for European adaptive platform trials and/or for cohort networks

Funding ProgramHorizon Europe - Cluster 1 - Destination 3: Tackling diseases and reducing disease burden
Call numberHORIZON-HLTH-2023-DISEASE-03-05
deadlinesOpening
12.01.2023		Deadline
13.04.2023 17:00
Funding rate100%
Call budget € 3,000,000.00
Estimated EU contribution per projectbetween € 1,000,000.00 and € 2,000,000.00
Link to the callec.europa.eu
Link to the submissionec.europa.eu

Call content

Call objectives

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 and a network for COVID-19 vaccine trials and strong common coordination mechanisms between the trials have been established. The recently launched Ecraid 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), the Global Health EDCTP3 Joint Undertaking, 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 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.

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Expected effects and impacts
Expected results
  • 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.

Regions / countries for fundingEU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
eligible entitiesEU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnershipNo
Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.

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.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible

Additional information

Topics
Disaster Prevention, Resilience, Risk Management, 
Health, Social Services, Sports
Relevance for EU Macro-RegionEUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 30 pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Call documents HE-Work Programme 2023-2024, Cluster 1, Destination 3 (556kB)
ContactNational Contact Points for Horizon Europe
Website

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