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Call key data
Pandemic preparedness and response: Adaptive platform trials for pandemic preparedness
Horizon Europe - Cluster 1 - Destination 3: Tackling diseases and reducing disease burden
Estimated EU contribution per project
between € 8,000,000.00 and € 10,000,000.00
Link to the call
Link to the submission
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”.
As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Health threats are expected to arise due to among others, climate change, and thus a need for proactive approaches to ensure timely availability of medical countermeasures during disease outbreaks is anticipated. The conduct of perpetual adaptive platform trials, with the in-built agility to pivot when an epidemic strikes, is key to be prepared for infectious disease epidemics or pandemics.
This topic aims to provide funding to adaptive clinical platform trials that may be implemented routinely outside of an epidemic or pandemic context, but that are designed to be ready for the timely assessment of novel diagnostics, therapeutics or vaccines in the face of an epidemic or pandemic.
Proposals should develop the wide range of elements needed to sustain multi-country adaptive platform trials, including the trial implementation capacity, laboratory analysis capacity, and a harmonised approach to the collection, storage, sharing and analysis of FAIR data.
Proposals should ensure timely engagement with regulatory authorities and bodies. Proposals should consider the European regulatory environment and take full use of the European capacity to deliver quality trials, including the possibility for registration of new medical products. Proposals should strengthen the leading role of the EU in clinical research preparedness for future epidemics and pandemics.
Expected effects and impacts
Proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:
- A diverse and comprehensive EU landscape of multi-country adaptive platform trials (i.e. able to study multiple interventions in a disease or condition in a perpetual manner, thus allowing modification to the trial after its initiation without undermining its validity and integrity) that assess vaccines and therapeutics for infectious diseases, and have the capacity to pivot rapidly in the case of epidemic or pandemic health threats.
- Innovative and improved design of clinical studies, suited for pandemic preparedness, is available for the clinical research community, taking into account the high safety standards in the European regulatory environment.
- Trial sites across multiple countries have the capacity to deliver robust clinical evidence in a diverse European population, using harmonised research methods, data collection and analysis.
The proposals should address the following areas:
- Development of robust clinical evidence that contributes to the knowledge base for the diagnosis, treatment and prevention of infectious diseases. Sex, gender, age, ethnicity and socio-economic factors should be taken into account.
- Known hurdles related to ethical, administrative, regulatory, legal and logistical aspects should be anticipated and addressed to the extent possible, in order to avoid such barriers when the trial needs to pivot in response to an epidemic or pandemic.
- Engagement with clinical researchers and biostatisticians, to increase capacity for the design and implementation of adaptive platform trials across Europe.
Collaboration and coordination with existing adaptive platform trials in the EU is expected, where relevant, as well as with the coordination mechanisms established under topic HORIZON-HLTH-2023-DISEASE- 3.05 and with the European Medicines Agency (EMA). Collaboration and coordination with other organisations and other regional and global initiatives, such as Global Health EDCTP3 Joint Undertaking, the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), the European Pandemic Preparedness Partnership and the European Health Preparedness and Emergency Response Authority (HERA) should be envisaged. International cooperation is encouraged.
This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
Regions / countries for funding
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
EU 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)
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, any legal entity established in the United States of America is eligible to receive Union funding.
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.
- 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.
Relevance for EU Macro-Region
EUSAIR - 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)
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).
This call follows a two-stage approach.
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly. Applicants submitting a proposal under the blind evaluation pilot must not disclose their organisation names, acronyms, logos nor names of personnel in Part B of their first-stage application.
The limit for a first-stage application is 10 pages. The limit for a full application (Part B) is 50 pages.
The award criteria are described in General Annex D. The following exceptions apply:
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Eligible costs will take the form of a lump sum.