Regulatory System Opportunities and Barriers for Conducting Clinical Trials in Ethiopia: A Descriptive Qualitative Study
Year: 2025
Type: article
Abstract: Background: Most clinical trials have been conducted in developed countries, and out of the total 343, 835 trials conducted worldwide only 157, i.e., 0.047% have been conducted in Ethiopia as of 26 June 2020. Ethics and regulatory review systems have been stated as the second most common barrier to trial development in Africa. All clinical trials to be conducted in Ethiopia have to get authorization from the Ethiopian Food and Drug Authority (EFDA). However,nbsp; no study has been done to investigate the effects of clinical trial regulation on clinical trial development in Ethiopia. In this study, we sought to study the enablers and barriers of the regulatory system for the conduct of clinical trials in Ethiopia. Method: A descriptive qualitative study was done. Thirteen clinical trial investigators and 2 staff working in the clinical trial team of EFDA were interviewed. The data were analyzed in a thematic way of analysis. Results: the establishment of a team in EFDA with a guideline and committed staff responsible for clinical trials regulation were opportunities; while inadequate staff, financial constraints, space shortage, lack of trial site follow-up inspection, absence of timely feedback to reports, and lengthy approval process were identified as barriers for the development of clinical trials in Ethiopia. Conclusion: In Ethiopia, clinical trial researchers face substantial ups and downs starting from clinical trial authorization to completion. Though the regulatory body is trying to facilitate clinical trial authorization and regulation, the system needs improvement by building and/or strengthening regulatory capacity to encourage investigators to conduct clinical trials in Ethiopia.
Source: Ethiopian Medical Journal
Authors: Maru, Mehiret, Makonnen, Eyasu, Woldeamanuel, Yimtubezinash
Institution: Addis Ababa University
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
Funder: Addis Ababa University
OpenAlex ID: W3166476543