Regulatory System Opportunities and Barriers for Conducting Clinical Trials in Ethiopia: A Descriptive Qualitative Study

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Addis Abeba University


Introduction: A clinical trial is a research method used to provide evidence on the safety and effectiveness of interventions for specific medical conditions. In contrary to the disease burden, most of the clinical trials were conducted in developed countries and the share of Africa as of 26 June, 2020accounts only around 2.98% of clinical trials done worldwide. Among the 10,249trials conducted in Africa only 1.53% has been done in Ethiopia. Different factors have been identified as a barrier for trial development in Africa and challenges associated with Ethical and regulatory system has been stated as the second most common barrier. The regulatory body is the one who authorizes and inspect clinical trials in Ethiopia. However, no study has been done so far on the opportunities and challenges of clinical trial regulation which affect trial development. Objective: In this study the enablers and barriers of the regulatory system on clinical trial development in Ethiopia is studied. Method: In this descriptive qualitative study, a total of 15 participants, who had experience in conducting clinical trials in Ethiopia and staffs working in Ethiopian Food and Drug Authority(EFDA) clinical trial team were identified from,, from a data obtained from EFDA and by snowball sampling and involved in the study. Then data was analyzed in the thematic way of analysis. Result: The presence of a specific team within EFDA with a guideline, and staffs initiation to regulate clinical trials are mentioned as an opportunity for clinical trial implementation. Different barriers such as lack of human resource and capacity, financial, infrastructure, regulatory guideline and directives, and trial site follow-up inspection are stated as a bottleneck for the researchers to do clinical trial in Ethiopia. Moreover, not having a feedback for reports, not taking part in the trials closeout and unreasonably stringent regulatory system also mentioned as a barrier. Conclusion and recommendation: In Ethiopia, clinical trial researchers face substantial up and downs starting from clinical trial authorization to trial completion. We recommend that there is a need to strengthen the capacity of regulatory body and develop efficient system in order to improve clinical trials regulation in Ethiopia.



Clinical Trial, Ethiopian Food and Drug Authority (EFDA), opportunity, barrier,challenge.