Eastern Africa Countries Need and Readiness for Implementation of Harmonized Clinical Trials Regulation and National Ethics Review System: A Qualitative Study

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Addis Abeba University


Background: Medical products are regulated from premarket clinical trials to post marketing surveillance and phase IV clinical trials. Research organizations have responsibilities to conduct clinical trials subject to regulatory and national ethics review process before putting products on the market. Harmonized approaches for regulation of clinical trials and national ethics review are practiced globally including in Eastern Africa countries under regional economic communities. However, there are gaps in medicine regulatory in general and clinical trials regulatory and national ethics review harmonization in particular. Objective: The aim of this study was to assess the need and readiness for implementation of harmonized clinical trial regulation and national ethics review in Eastern Africa. Methodology: A qualitative study was conducted in selected Eastern Africa countries focusing on regional economic communities (RECs). Data were collected through semi structured questionnaire from National Regulatory Authorities, National Ethics Review Committee, development partners, sponsor and research institutions through email by assigning facilitators in each country, and were analyzed thematically using QDA Miner Lite qualitative data analysis software. Specific countries regulatory and ethics review system components were analyzed according to the nature of questions and responses. Results: It was noted that 5 Eastern Africa countries involved (Ethiopia, Kenya, Sudan, Uganda and Tanzania) in the present study had national legislations for medicines and clinical trials regulations. Shortage, lack of experience, lack of appropriate expertise and poor professional mix were staff related problems identified in this study. It was noted that clinical trial structures were established at directorate level in one country, at team level in three countries and none in one. These findings reflect countries readiness for implementation of harmonization initiative. Capacity building, utilizing limited resources in the region and ensuring quality were some of need related findings for implementation of harmonized approach. Existence of platforms like RECs, partners support and enabling conditions were identified opportunities for implementation of harmonized regulation and national ethics review. Challenges identified were lack of awareness, difference in administrative procedures, lack of commitment, resource limitation, and requiring long time for implementation of harmonization. Differences were also noted among countries and RECs (IGAD and EAC) in regulatory system and progress in implementation of harmonization initiative respectively. Conclusion: The readiness of most of the countries in regulating clinical trials is not adequate to implement harmonized clinical trials regulation and national ethics review. However, there is remarkable need for harmonization in the region. Countries need to strengthen their clinical trial regulatory and national ethics review system in consideration of harmonization.



Harmonized Clinical Trials Regulation, National Ethics Review, Eastern Africa Countries