Quality Safety and Standards, Department of Immunization, Vaccines and Biologicals, WHO, Geneva, Switzerland.
Vaccine. 2009 Dec 9;27(52):7249-52. doi: 10.1016/j.vaccine.2009.08.113. Epub 2009 Sep 11.
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.
随机对照临床试验是确定药物治疗或预防价值的最佳方法。近十年来，临床试验的地点从工业化国家向发展中国家转移，包括许多非洲国家。然而，如果没有对临床试验进行独立的、强有力的监管和伦理监督，就无法核实研究对象的安全性和临床数据的科学性。本文描绘了非洲临床试验监管的情况，以支持重点药品的开发，重点介绍了过去 5 年在世卫组织指导下各国所面临的挑战和取得的进展。
