European and Developing Countries Clinical Trials Partnership (EDCTP)

EDCTP represents results and innovation put into practice. EDCTP has supported multiple studies that have influenced national and international policy and practice: Data from the CHAPAS trials contributed to the approval of fixed-dose antiretroviral drug formulations for children by the US Food and Drug Administration, paving the way for their distribution through global philanthropic programmes and greatly enhancing African children’s access to life-saying antiretroviral drugs. The Kesho Bora study provided some of the earliest and strongest evidence that triple antiretroviral therapy could dramatically reduce mother-to-child transmission of HIV during breastfeeding. It informed the development of revised WHO guidelines, which recommended more extensive use of antiretrovirals in pregnant and breastfeeding women. The WANECAM study demonstrated the safety and efficacy of an antimalarial formulation specifically developed for children, paving the way for its approval by the European Medicines Agency and recommendation by WHO. <br />
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EDCTP has supported projects developing regulatory systems and ethical review capabilities in 24 sub-Saharan African countries, helping to create enabling environments for high-quality research. EDCTP is a member of the newly established African Medicines Regulatory Harmonisation Partnership Platform, to improve coordination of regulatory systems strengthening and harmonisation activities in Africa. EDCTP also has a long-term working relationship with WHO-AFRO, which hosts the African Vaccine Regulatory Forum (AVAREF). EDCTP funding contributed to the establishment of AVAREF.<br />
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The Pan African Clinical Trials Registry (PACTR) is the first WHO recognised clinical trials registry in Africa. PACTR aims to be a comprehensive database of planned, on going or completed clinical trials in Africa.<br />
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EDCTP-funded Networks of Excellence in four African regions have created platforms for high-quality clinical studies spanning multiple sites and enabled the sharing of research experience, expertise and knowledge, developing sustainable capabilities across 63 institutions in 21 African countries to date.<br />
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Several EDCTP-funded consortia bring together large numbers of partners from Africa and Europe, including the Pan-African Network for Rapid Research, Response, Relief and Preparedness for Infectious Diseases Epidemics (PANDORA-ID-NET, 22 partners), the African Coalition for Epidemic Research, Response and Training (ALERRT, 21 partners) and the West African Network for TB AIDS and Malaria (WANETAM, 20 partners), which facilitate research collaboration between diverse institutions in the four regions of sub-Saharan Africa and strive to collaborate with similar initiatives at country and regional level, in order ensure sustainability and avoid duplication. In addition, the networks actively seek political and financial support from African national governments and regional economic committees.<br />
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Joint calls with WHO have developed capacity in responding to Ebola outbreaks, clinical research and implementation research. <br />
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Participation of industry and PDPs in EDCTP consortia have enabled African academic institutions to further develop their capacity to undertake trials compliant with the rigorous standards demanded of regulatory studies.