A decade of partnership

Prof. Charles MgoneThe European & Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by HIV/AIDS, tuberculosis and malaria. Its first objective was to accelerate the development of new or improved interventions towards prevention and treatment of these three major poverty-related diseases especially by supporting clinical trials. Its second objective was to facilitate cooperation and integration of relevant European national research programmes and activities. These two objectives were to be accomplished through working in partnership with sub-Saharan African countries and like-minded organisations.

The partnership
EDCTP was devised as an initiative based on Article 185 (ex-Art. 169) of the Treaty on the Functioning of the European Union, which allows the EU to participate in research programmes undertaken by several EU Member States. The EDCTP partnership currently comprises 16 European Participating States (14 EU Member States and 2 associated European countries) and sub-Saharan African countries.

With support of the EU, the EDCTP programme brought together the combined strengths of its European Participating States with those of their sub-Saharan African counterparts and interested third parties in order to address the global challenge of fighting poverty-related infectious diseases, which is beyond the capacity of individual countries. It facilitated cross-border research in Europe and sub-Saharan Africa and contributed to the development of the European Research Area. The programme also promoted sustainability and African ownership through support of capacity building in sub-Saharan African countries. Through EDCTP, European countries had a coherent and coordinated voice internationally and a common strategy for clinical research to fight poverty-related infectious diseases.

Integrated projects for sustainable research
EDCTP has developed a programmatic funding approach that focuses on clinical trials as the core activity and supports networking and capacity development integrated with the clinical trials.

Targeting HIV/AIDS, tuberculosis and malaria, EDCTP has funded clinical trials on treatment drugs, vaccines, microbicides and diagnostics. Through its funding instruments, it has contributed to the coordination and integration of national research programmes. Results from various trials have informed national and international policies such as the WHO policy on the prevention of mother-to-child transmission of HIV and the registration of a paediatric formulation of an antiretroviral product (Pedimune) in several African countries. Furthermore, in its first decade, EDCTP provided professional training to 514 African scientists and medical doctors, including 56 Career and Senior Fellows as well as more than 406 Master’s and PhD students.

Overall, EDCTP represents a flagship programme for conducting sound multi-country clinical trials in sub-Saharan Africa, building a true partnership between Europe and Africa, and fostering African leadership in scientific research. Europe’s strong commitment to partnership is reflected in the fact that 74% of EDCTP funding was invested into activities implemented by African research institutions and 72% of all EDCTP-funded projects were led by African researchers.

The EDCTP programme also contributed to networking African research which resulted in the launch of four African Regional Networks of Excellence for clinical trials. Moreover, the ethics and regulatory environment has been improved by strengthening ethics review capacity and national regulatory authorities in many African countries. EDCTP was the main funder of the African initiative to establish the Pan African Clinical Trials Registry (PACTR, www.pactr.org), which is now an official WHO Primary Clinical Trials Registry.

Towards EDCTP2
Based on the progress so far, the second EDCTP programme (EDCTP2) will be implemented from 2014 to 2024 as part of the next European Framework Programme for Research and Innovation - Horizon 2020. Its scope is based on the current objectives and achievements and will be expanded to include all clinical trial phases (I-IV); neglected infectious diseases (those in the WHO-TDR list of Neglected Tropical Diseases, except Chagas disease, in addition to diarrhoeal and respiratory infections); diagnostic tools; and health services optimisation research. The new programme will also see a stronger partnership, with more European and African countries participating, and increased collaboration with the pharmaceutical industry, product development partnerships, philanthropic organisations and development agencies. As global efforts are required to address poverty-related and neglected infectious diseases, partnerships and synergy with other funders which support research outside sub-Saharan Africa, will be necessary.

EDCTP aims to integrate and align national programmes and projects into one strategically coherent Joint Programme. The current Participating States, with the exception of Belgium, expressed the political will to support EDCTP2. New European countries, including Finland and Latvia, as well as several African countries, expressed interest to join EDCTP2 as members of its new legal framework. By the end of 2013, the total financial commitment to the second programme was an estimated € 1.366 billion. The expanded scope of EDCTP will transform the initiative into a major global player in product development for poverty-related and neglected infectious diseases as it will have increased financial resources to provide leadership in funding clinical testing and developing safe and efficacious products for poverty-related and neglected infectious diseases. EDCTP is expected to move from a collaborative research programme to a programme that will contribute to the long-term sustainable development of sub-Saharan Africa.