title: Regulatory oversight of clinical trials in Africa: progress over the past 5 years.
abstract: Randomized controlled clinical trials represent the best way to establish the therapeutic or preventive value of medicines. This decade has seen a strong shift in the location of clinical trials from industrialized countries to developing countries, including many in Africa. However, without independent strong regulatory and ethical oversight of clinical trials the safety of research subjects, and scientific integrity of clinical data cannot be verified. This article draws up a portrait of clinical trials regulation in Africa in support of development of priority medicines, highlights challenges and presents the progress made by countries under WHO guidance over the past 5 years.
authors.affiliation: Quality Safety and Standards, Department of Immunization, Vaccines and Biologicals, WHO, Geneva, Switzerland.
authors.forename: Diadié
authors.initials: D
authors.lastname: Maïga
authors.forename: Bartholomew Dicky
authors.initials: BD
authors.lastname: Akanmori
authors.forename: Liliana
authors.initials: L
authors.lastname: Chocarro
mesh_terms: D000349:Africa; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D035842:Research Subjects; D014612:Vaccines / Q000592:standards; D014944:World Health Organization
chemical_list: D014612:Vaccines