HORIZON-JU-GH-EDCTP3-2025-03-NETWORKS-01-two-stage
General information
Programme
Horizon Europe (HORIZON)
Call
Type of action
HORIZON-JU-CSA HORIZON JU Coordination and Support Actions
Type of MGA
HORIZON Lump Sum Grant [HORIZON-AG-LS]
Forthcoming
Deadline model
two-stage
Planned opening date
30 January 2025
Deadline dates
20 March 2025 17:00:00 Brussels time
02 September 2025 17:00:00 Brussels timeTopic description
Expected Impact:
Expected impact
The actions funded under this topic should contribute to increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investments in order to achieve the strengthening of the Regional Networks of Excellence and Epidemic Preparedness Consortia. Proposals are expected to leverage and include the effective in-kind and/or financial contribution of contributing partners, in order to produce meaningful and significant effects enhancing the impact of therelated research activities.
Applicant consortium
The contributions from contributing partners should correspond to the amounts they have committed in the letter of endorsement requesting to become a contributing partner (Article 9 Council Regulation (EU) 2021/2085). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit the endorsement letter for approval by the Global Health EDCTP3 Governing Board before the deadline for submission of the second-stage applications. It is recommended that the draft letter is submitted to the Global Health EDCTP3 Programme Office sufficiently ahead of deadline for submission of proposals to allow the review[1].
In case of in-kind contribution (even combined with financial contribution), contributing partners become a part of the applicant consortium and participate in the project, as appropriate i.e. as beneficiaries orAffiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement.
[1] The Global Health Programme Office will ask the applicant contributing partner to revise the letter in case it significantly departs from the template letter published on the Global Health EDCTP3 JU website or is missing any compulsory elements. The preliminary assessment by the Programme Office does not consider the merits of the application. The final decision as to acceptance or rejection of a new contributing partner rests with the Global Health EDCTP3 JU Governing BoardExpected Outcome:
Background
The burden of recent outbreaks of Ebola Virus Disease (EVD), Mpox, Cholera along with the recent COVID-19 pandemic has been tremendous in terms of lives lost. Attempts were made during the epidemic to develop and evaluate vaccines, treatments, and diagnostics for EVD, but these were hampered by weak systems and capacity was not in place to carry out these activities on a very rapid timescale.
The earlier EDCTP Programmes have made important long-term investments towards the African clinical trials ecosystem through the regional networks of excellence, the epidemic preparedness and other related collaborative clinical research activities. The EDCTP consortia for Epidemic Preparedness were ready to carry out research response in several outbreaks across countries that were hosting the projects. It is vital that capacity is strengthened and further developed to undertake rapid evaluation of interventions in clinical trials when future outbreaks occur of emerging or re-emerging diseases. In parallel, strengthening surveillance systems to detect such outbreaks at an early stage, and strengthening laboratory systems to rapidly confirm diagnoses, are of high priority. Assembling background clinical and epidemiological data now on diseases that are currently prevalent and have epidemic potential, will facilitate the planning of clinical trials of new interventions, such as vaccines and treatments, as these are developed.
There are significant clinical research disparities and a very heterogeneous clinical research landscape for conducting clinical trials in SSA across African researchers, institutions, countries and sub-regions.Fostering research collaborations is a means of addressing this challenge through investing in a joint pathway towards a stronger and sustainable SSA clinical research landscape. It is important to invest in efforts that will enable effective management of infectious diseases with epidemic potential using evidence- based preventive methods, prompt laboratory diagnosis, timely treatment, protection of healthcare workers and at the same time ensuring geographical containment.
Alignment and coordination with key players in the field is important to ensure complementarity of investments. Building on EDCTP2 investments and in collaboration with key global health partners (GF, PEPFAR, CEPI, Africa CDC), the Global Health EDCTP3 aims to strengthen the pre-established Networks of Excellence and Epidemic Preparedness Networks, through disease specific networks nodes (such as TB, HIV/AIDS, Malaria and NTDs depending on disease epidemiology and the networks’ regional priorities), and horizontal functions weaved in the current health security architecture coordinated by the Africa CDC.
Expected Outcome
The purpose of this topic is to provide funding to restructured EDCTP Regional Networks tailored to the evolving regional clinical trials landscape and learnings from COVID-19, as well as other regional disease threats, towards achieving the pre-defined deliverables set out in this call.
Building on EDCTP2 investments, proposals under this topic should aim to deliver results that are directed, tailored towards, and contributing to the following expected outcomes. Proposals need to address all the following outcomes:
- Strengthening clinical research capacity in order to be able to conduct multi-country clinical trials to ICH-GCP standards and compliance with WHO Guidance for Best Practices for Clinical Trials [1];
- Enhancing collaboration and optimising the use of resources and infrastructures within the network;
- Offering training, mentorship and support to senior scientists to promote professional developmentand scientific leadership in clinical trials;
- Strengthening South-South, North-North and North-South collaborations between researchers and institutions;
- Encouraging and promoting networking and dialogue between researchers, communities and policy makers to maximise the impact of clinical research in Africa;
- Promote resource sharing and harmonisation;
- Establishing or strengthen partnerships with National Public Health Institutes;
- Establishing/strengthening/expanding multidisciplinary epidemiology networks, generating accelerated evidence for optimal management of patients and for guiding public health response to any severe infectious outbreak caused by pathogens within the scope of the Global Health EDCTP3.
[1] Guidance for best practices for clinical trials (who.int)Scope:
Scope
Proposals must address three of the following areas:
1) Expertise
- Strengthening expertise on clinical research in all disease areas in the scope of the Global Health EDCTP3. Proposals aiming to strengthen expertise on HIV/AIDS clinical research are encouraged to align with activities supported by PEPFAR across SSA;
- Strengthening expertise and preparedness for research response to emerging and re-emerging diseases with epidemic potential. Proposals aiming to strengthen expertise and preparedness for research response to emerging and re-emerging diseases with epidemic potential are encouraged to align with activities supported by other funders;
- Supporting National Public Health Institutes in collaboration with Team Europe Initiative “Supporting Public Health Institutes in Africa” [1]. Strengthening/establishment, in conjunction with African CDC, of at least one ICH-GCP-compliant clinical trial site (compliant with WHO Guidance for Best Practices for Clinical Trials [2]) conducted and managed by appropriately qualified staff within the network;
- Pool of interdisciplinary experts organised in networks including at least one NPHI, able to provide accelerated evidence on infectious diseases;
- Training of a specified number of clinical research associates, certified to monitor clinical trials and can be contracted by the Global Health EDCTP3, other funders or clinical trial sponsors to monitor the progress and quality of clinical trials ;
- Strengthening the ethics, regulatory, and pharmacovigilance capacities.
2) Training, mentorship and support to senior researchers
- Develop a comprehensive training and mentorship plan to support the career development of talented individuals through dedicated courses, short term staff exchange programmes, and active rotation process among sites for mentors/trainers and trainees;
- Support a specified number of senior researchers to conduct a research project leveraging the infrastructure, network and expertise supported through this call and EDCTP2 funding.
3) Partnerships
- Enhance South-South and North-South collaboration, and strengthen partnership with National Public Health Institutes and regional public health bodies;
- Propose a sustainability plan and networks that can be pivoted to respond to outbreaks within the respective sub-regions;
- Provide a coordination function to align with Africa CDC and other funders’ strategies and activities to strengthen the African clinical trial ecosystem.
4) Infrastructure
- Upgrade at least one additional clinical laboratory, accredited to the GCLP standards;
- Develop/upgrade or expand a functioning data management service, which can be used by the network or contracted by external clinical trial sponsors.
Proposals submitted against this topic are expected to leverage financial and/or in-kind contribution from contributing partners. Proposals should define the activities of their project in its entirety, including details of the component(s) for which Global Health EDCTP3 JU funding is requested and the component(s) that are to be financed by contributing partners.
Proposals should include consortia with strong representation from institutions and researchers across sub- Saharan African countries, demonstrating a broad regional distribution in the SSA region, including involvement of new institutions and Franco/Lusophone countries, and considering previous EDCTP 1 and 2 investments and current EDCTP3 call. Applicants are also reminded of the expectation of reaching out to organisations in countries with high burden of disease with relatively lower research capacities, for which appropriate funding allocations should be proposed. Collaboration with other international research groups with relevant experience and participation in networking and joint activities, as relevant, is strongly encouraged.
FAIR data principles and open access of publications are required in line with the Model Grant Agreement [3] when relevant.