Good clinical practice in East Africa: A review

Abstract

Objective: 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. Data sources: 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®. Conclusion: The advancing capacity for clinical research in East Africa will be accelerated by harmonising clinical research requirements and guidelines.