Eastern Africa Countries Need and Readiness for Implementation of Harmonized Clinical Trials Regulation and National Ethics Review System: A Qualitative Study
No Thumbnail Available
Date
2020-11
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Abeba University
Abstract
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.
Description
Keywords
Harmonized Clinical Trials Regulation, National Ethics Review, Eastern Africa Countries