Good clinical practice in east Africa: a review.

Abstract

To call for harmonisation of good clinical practice guidelines in East Africa as one of the necessary precedents to enhancing their quality and quantity in the region. There were two main sources of background information for this review. The first was a series of articles discussing and documenting the harmonisation process in East Asia and in Latin America. The other was a short survey conducted in Kenya in July 2000. STUDY AREA SELECTION: Most of the survey participants were drawn from the Kenya Medical Research Institute (KEMRI) in Nairobi, Kisumu and Kilifi with a few coming from the vicinity of these areas. DATA PROCESSING AND ANALYSIS: The survey tool was a fourteen page questionnaire seeking information in various areas. These were: personal information, general clinical research information, medical practitioners, clinical research experience, human subject participation, sponsors, clinical trial supplies, investigator sites and general comments. Data entry was performed in Microsoft Access. Forty four researchers participated in a period of three weeks. Data summaries and reports were performed in SAS. The advancing capacity for clinical research in East Africa will be accelerated by harmonising clinical research requirements and guidelines.