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Preparations are underway for a second phase of the European & deg Developing Countries Clinical Trials Partnership programme (EDCTP2, 2014-2024), which is expected to start in the course of 2014 as part of the EU's Horizon 2020 research funding programme. 

This phase will carry on the life-saving work of the first programme (EDCTP1, 2003-2012), which aimed to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against poverty-related diseases, more specifically on HIV/AIDS, tuberculosis and malaria. It funded clinical trials in sub-Saharan Africa with a focus on phase II and III of clinical development. EDCTP1 also supported capacity building and networking in order to create an enabling environment for conducting these trials in sub-Saharan Africa in line with international and European standards of scientific, ethical and clinical conduct. 

The programme has been hugely successful. Under EDCTP1, a total of 241 projects were financially supported by EDCTP promoting African-European and notably trans-African research partnerships. The projects included 88 clinical trials: 31 on HIV/AIDS, 25 on tuberculosis and 32 on malaria. 

While most clinical trials are still on-going, positive results have been achieved. A study of highly active antiretroviral therapy during pregnancy and breastfeeding, for example, demonstrated a 43 per cent reduction in HIV infections in infants and more than 50 per cent reduction of mother-to-child transmission during breastfeeding. 

A malaria trial (4ABC) was conducted at 12 centres in seven sub-Saharan African countries (Burkina Faso, Gabon, Mozambique, Nigeria, Rwanda, Uganda and Zambia). More than 10,000 children between 6 and 59 months old were screened, and a total of 4116 children were included in the study and treated. Three novel artemisinin-based combination drugs were found to be safe and effective in treating children with a certain type of malaria. 

A project examining severe malaria in children has also been successful, demonstrating that three doses of intravenous artesunate (a drug to treat malaria) over two days is as effective as five doses over three days. This finding has the potential to lower costs and reduce the risk of complications or incomplete treatment. A follow-up clinical study aims to further optimise the administration of the drug. 

EDCTP1 has also provided 420 career and training awards to African scientists, including 50 senior fellowships. Almost all senior fellows continued working in their respective countries after the expiration of the grant. More than 1300 research collaborators in Africa and almost 800 in Europe have cooperated so far in EDCTP-funded activities. 

Building on the success of the first phase the scope of the EDCTP2 programme may be expanded. This would allow EDCTP to also support clinical trials on other poverty-related diseases - such as neglected infectious diseases like sleeping sickness - at any stage of clinical development, including costly marketing authorisation trials for new vaccines or drugs, and to foster optimised delivery of better health solutions for the specific population groups in need. 

In order to prepare for EDCTP2, the Commission has a dedicated FP7 Support action known as EDCTP-Plus. Its activities are laying the foundation for implementing and managing the EDCTP2 programme in view of the proposed expansion and increased budget. 

The EDCTP was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases of HIV/AIDS, tuberculosis and malaria. Notwithstanding progress made, these three diseases accounted for over 3.5 million deaths in 2012, with the greatest burden of disease in sub-Saharan Africa, where besides ravaging lives, they impede development and cause poverty. 

EDCTP currently unites 14 EU Member States plus Norway and Switzerland with sub-Saharan African countries. Its governance involves representatives of these European countries and sub-Saharan Africa. The programme is co-funded mainly by these European countries and the European Union while some co-funding is also provided by third parties, such as the Bill ° Melinda Gates Foundation and pharmaceutical industries.

Source: http://cordis.europa.eu

Jul 25, 2013