The Global Health EDCTP3 Joint Undertaking (GH EDCTP3) builds on the first and second European and Developing Countries Clinical Trials Partnership programmes. This new joint undertaking (JU) is a partnership between the EU and the EDCTP Association, whose members are several European and African countries. The partnership will deliver new solutions for reducing the burden of infectious diseases in SSA and strengthen research capacities to prepare and respond to re-emerging infectious diseases in this region and across the world.
This topic aims at supporting activities that contribute to one or several of the expected outcomes for this call.
Proposals under this topic should aim to deliver results that are contributing to at least one of the following expected outcomes:
Scope includes infectious diseases in scope of the Global Health EDCTP3 including HIV/AIDS. Proposals are to generate beyond proof-of-concept data.
Out of scope: infectious diseases not in scope of the Global Health EDCTP3, potential solutions tacklingchronic diseases potentially caused by infections, and non-communicable diseases.
Applicants are invited to address the following in the proposals:
Proposals should clearly define the challenge or unmet need they are addressing. Applicants must provide a rationale explaining why this gap has not yet been successfully addressed and how their innovation will overcome these barriers. The proposal should highlight the unique value proposition and potential transformative impact of the innovation. Special attention should be paid to how the innovation serves vulnerable or underserved populations as relevant.
Proposals should present a comprehensive strategy for engaging communities and relevant stakeholders, most notably (local) key opinion leaders, researchers, health care professionals, policy makers, regulatory bodies, public health authorities, supply chain actors and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines when relevant.
For innovations with a technological component, applicants should outline a clear roadmap for technology transfer, ensuring that the innovation can be scaled sustained by local or regional entities. The roadmap should include productisation pathways outlining how the innovation will transition from development to practical application. Proposals should also encourage local ownership by ensuring that the necessary skills and capacity building for long-term sustainability are embedded in the project.
Proposals should clearly describe the desired target product profile. Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available). Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation, and an access strategy that will allow patients in low-resource settings to access the final product.
Where relevant, proposals should demonstrate early engagement with regulatory bodies and manufacturers to facilitate the timely translation of innovations into affordable, regionally available products. Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) or similar African initiative is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts – including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged.
Applicants are also reminded of the expectation of reaching out to institutions/organisations in countries with high disease burden but with relatively lower research capacities.
Expected EU contribution per project: €1.400.000 – €2.330.000
EDCTP – Europe Office
Postal and visiting address: Anna van Saksenlaan 51, 2593 HW The Hague, The Netherlands
Telephone: +31 70 344 0880
EDCTP – Africa Office
Postal address: P.O. Box 19070, Tygerberg 7505, Cape Town, South Africa
Visiting address: Francie van Zijl Drive, Parowvallei 7505, Cape Town, South Africa
Telephone: +27 21 938 0690
Fax: +27 21 938 0569
Contact Form in the website