Scope

Clinical research and clinical trials for preventing and treating HIV/AIDS, tuberculosis and malaria diseases have been identified as major priorities for EDCTP. In the past, new tools for the prevention and treatment of the three diseases were stuck in the development pipeline. Market opportunities were restricted, and research activities were fragmented and uncoordinated. New and specific requirements such as the need for multi-centre protocols, a demanding regulatory environment and universal ethical standards require well-coordinated and intensified effort in a genuine and innovative partnership with developing countries.

Primarily, EDCTP funds phase II and III clinical trials on HIV/AIDS, tuberculosis and malaria in sub-Saharan Africa. To create an enabling environment for carrying out these trials, EDCTP also enhances research capacity in Africa, provides a platform for collaboration across research networks and national programmes, acts as a broker for more research into product development, and encourages translational research that informs policy. It also ensures an enabling environment for conducting these trials by strengthening capacities in ethics review and regulatory affairs. The following diagram shows the scope and how EDCTP provides support for trials:

EDCTP does not discover products and is not a product development organisation. EDCTP’s involvement starts after approval for first-in-human studies has been granted to a product. Nevertheless, EDCTP closely follows new developments in the late discovery or pre-clinical stages and constantly interacts with scientists, developers and the broader scientific community to formulate strategic plans around promising candidates. Therefore, EDCTP does not develop tools independently, but acts as a partner that supports platforms for clinical trials to facilitate clinical development and transfer of technologies to sub-Saharan Africa.