The European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership between 14 European Union Member States (MS) and 2 associated countries with sub-Saharan African countries.
The aim of the programme is to accelerate the development of new and improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis, malaria and other neglected diseases. The programme functions through a balanced partnership of European national research programmes on PRDs with their African counterparts in collaboration with the pharmaceutical industry and like-minded organisations. This includes funding clinical trials, supporting ethical reviews and the strengthening of regulatory frameworks, training personnel, upgrading infrastructure and networking.
EDCTP also aims to increase African research capacity to tackle these diseases and to support the integration of the national research programmes of EU Member States (MS) working in these disease areas. Outside direct support for clinical trials, EDCTP has made significant progress in many other areas such as building research leadership, increasing joint funding of large trials, and developing research collaboration. This programme of action has been scaled up from 2014 under EDCTP2. Under EDCTP2, the programme has moved into funding research in neglected infectious diseases (NIDS) and extend into Phase I and Phase IV clinical trials, as well as health services optimisation research.
Objective of the research
To achieve its aims, EDCTP2 needed to promote increased collaboration and cooperation amongst and between researchers in Europe and sub-Saharan Africa. The research conducted by Baird’s CMC would help in identifying and leveraging resources (including funding for clinical research), expertise and opportunities in the field of HIV/AIDS, tuberculosis, malaria, NIDs and health systems/operational research, and describing how these activities and capacities relate to both African national disease control programmes and the mission of EDCTP. The report would be used to inform the scope, remit and strategy for EDCTP2 in order to maximise the participation of African researchers. The analysis would also serve as a baseline against which the activities and achievements of EDCTP2 in capacity building could be measured.
Scope of the research
The research took place in-country over two phases across all 47 sub-Saharan African countries. Phase 1 covered 17 countries in Central and Eastern Africa, with fieldwork taking place in 1H13. Phase 2 covered the remaining 30 countries in West Africa and Southern Africa, and took place in 2H13.
Respondents were selected from the following groups:
- Civil servants responsible for commissioning and funding clinical research from relevant government ministries/departments (normally Ministry of Health, or Ministry of Finance/Planning, Budget)
- Faculty/researchers in university departments or other national research institutions
- in-country officials of bilateral and multilateral organisations with an interest in research (e.g. WHO country or regional office, Global Fund, UNICEF, Sabin Institute, UNAIDS)
- In-country representatives of national development agencies with a focus on health research and capacity-building (e.g. USAID, DfID, Sida, Danida, etc.)
- Individuals working with relevant civil society organisations/NGOs
- Journalists who have written about these issues and have specialised in this area.
In total, 303 interviews were completed and reported in a standardised format.
Analysis was conducted by RAND Europe based on the fieldwork conducted by Baird’s CMC. The analysis was supplemented by a comprehensive literature review in indexed sources and grey literature.
Research was completed in 46 countries – ongoing armed conflict and lack of a functioning government in Central African Republic meant it was not possible to conduct fieldwork there.
The research threw up some interesting findings which can be accessed from the report on the EDCTP website. In particular, respondents emphasised the importance of involvement of policymakers in supporting development of research capacity (often ranking it more important than funding or infrastructure).