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Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

Foreword

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Message from the Executive Director

Dr Michael Makanga
EDCTP Executive Director

Dear colleagues, partners and friends,

I find a great deal to be encouraged by in the 2018 annual report. This year represents an important milestone, the 15th anniversary of the creation of EDCTP in 2003. It also marks the fifth year of implementation of the second programme of EDCTP. The facts and figures for the year are exciting and our overall portfolio of projects has continued to grow by more than a third. Researchers in 17 European and 36 sub-Saharan African countries are now working on EDCTP-funded projects addressing the key infectious disease threats facing Africa – including HIV, malaria, tuberculosis, neglected tropical diseases and emerging diseases. Their work is advancing the development of drugs, vaccines, diagnostics and other interventions that will make a real difference to the lives of people across the continent.

Eleven calls for proposals were launched in 2018. This brings the total number of calls launched under EDCTP2 to 42. By the close of 2018, 192 proposals had been selected for funding, of which 148 projects had already started. The cumulative EDCTP2 grant funding has more than doubled compared to EDCTP1, reaching a total of € 447.15 million.

We aim for a balanced research portfolio covering the range of diseases in our scope and focusing on the priority areas identified in our Strategic Research Agenda. 

Clinical trials receive the bulk of the EDCTP budget. The total investment has now reached €395.83 million, supporting 82 large-scale trials. Just over half are phase II and III trials, and many target key populations, including pregnant women, newborns, children and adolescents. A further 12% of the clinical research grants involve post-licensure (phase IV) studies, including product-focused implementation studies, generating evidence highly relevant to policymakers on how best to deliver new interventions of proven efficacy in the real-life setting of clinic, hospital or community.

In the area of capacity development, EDCTP has now invested in 89 fellowship grants, supporting the career development of current and aspiring African scientific leaders. The profiles of current and former EDCTP fellows are available on the EDCTP Alumni Network platform, which was launched in 2017.

EDCTP supports the development of an enabling environment for clinical research in several ways. We strengthen national and regional regulatory and ethical review capacities – with 24 countries benefiting from 20 such grants to date. Four EDCTP regional networks are developing as centres of excellence for clinical trials, and three grants support national pharmacovigilance activities to build capacity for using research evidence in policymaking. 

EDCTP was also part of the TRUST ethics consortium. It’s main deliverable was the Global code of conduct for research in resource-poor settings, which was presented at the European Parliament in June 2018. Adopted as a resource, it is available to applicants and grant-holders via the Horizon 2020 Online Manual. Regarding regulatory affairs, EDCTP is now a member of the African Medicines Harmonisation Partnership Platform coordinated by the African Union.

Targetting the specific needs of African and European beneficiaries of EDCTP2 grants, several workshops were organised by the EDCTP Secretariat: two grant writing workshops in Portuguese and French, one on advanced Good Clinical Practice (GCP) for trainers of trainers, and two regional workshops on financial and project management.

In the area of EU coordination, EDCTP Participating States’ total cash contribution had grown to €121 million by the end of 2018. Reporting of the contributions via the activities initiated by the Participating States (PSIAs) is ongoing and moved in a positive direction in 2018. Furthermore, the joint WHO-AFRO/TDR/EDCTP Small Grants Scheme was launched through a collaboration between three EDCTP member countries: Germany, Sweden and UK. This resulted in funding for 30 sub-Saharan African researchers to carry out implementation research for infectious diseases of poverty in the context of health research systems.

Partnerships are at the core of our work. African participation in the EDCTP Association increased from 14 to 16 since the start of EDCTP2, with Nigeria and Ethiopia admitted as new members, and Angola becoming an aspirant member. There are 14 European members of the EDCTP Association. At the end of 2018, 230 African and 139 European institutions in 61 countries (36 in sub-Saharan Africa, 19 in Europe) and institutions in six other countries are involved in EDCTP projects. On average, EDCTP’s clinical research projects are conducted by multi-disciplinary consortia from more than 6 countries, bringing together not-for-profit and for-profit partners from the public and private sectors. The EDCTP2 programme is expected to leverage project contributions of €295 million (total cash and in kind) from global partners including the US National Institutes of Health, the President’s Emergency Fund for AIDS Relief, the Gates Foundation, Mundo Sano Foundation, the TB Alliance, Serum Institute of India and others. 

To ensure that our research delivers public health impact, EDCTP has sought to build partnership with development agencies. An EDCTP call for proposals to support health research systems resulted in the establishment of three consortia and funding from two development cooperation agencies: U.S. Agency for International Development (USAID) and the Swedish International Development Cooperation Agency (SIDA). These projects entered into their implementation phase in 2018. A second call for proposals on ‘Capacity development to facilitate delivery and uptake of new or improved medical interventions in African health systems’ was launched in 2018.

Moreover, EDCTP organised a side meeting on strengthening national health research systems in Africa during the 68th session of the WHO Regional Committee for Africa in Dakar, Senegal. The meeting brought together representatives from governments, including African ministers of health, regional bodies, regulators, policy makers, and strategic partners committed to research and strengthening national health research systems in Africa.

The Ninth EDCTP Forum took place in Lisbon, Portugal from 17-21 September 2018 with 550 participants from more than 50 countries. The Forum was hosted by the Portuguese Foundation for Science and Technology and the Calouste Gulbenkian Foundation. Its theme was ‘Clinical research and sustainable development in sub-Saharan Africa: the impact of North-South partnerships’. 

Looking forward, we have begun to consider what a successor programme to EDCTP2 might look like, building on the unique features and successes of its forerunners. Fruitful discussions were held at two high-level meetings, in Africa (Dakar, Senegal) and in Europe (Lisbon, Portugal).

Finally, we greatly appreciate the commitment and efforts of our many partners. We are very thankful to the many African and European researchers as well as the volunteers participating in the studies we fund. Special thanks go to the members of the EDCTP Board, the General Assembly, the Scientific Advisory Committee, the Audit Committee, all independent scientific review committees, the European Commission Officers responsible for EDCTP matters, and the members of the Executive Secretariat who have worked diligently to make 2018 successful.

The Ebola outbreak in the Democratic Republic of the Congo, the second largest ever recorded, is a reminder of the continuing threat posed by emerging infections. In 2018, we launched an emergency Ebola funding initiative, supporting five projects conducted by 24 institutions in Africa and Europe. In addition, two large EDCTP-funded consortia – ALERRT and PANDORA-ID-NET – are working to enhance the capacity of African regions to prepare for and respond to infectious disease outbreaks. A joint funding initiative with WHO/TDR launched in 2015 to strengthen capacity to conduct research during infectious disease outbreaks supported six projects which are concluding successfully this year and in 2019.