TITLE:
Comparative Study of Clinical Trials Regulatory Oversight in Burkina Faso and Senegal
AUTHORS:
Youssou Ndao
KEYWORDS:
Regulation, Oversight, Clinical trials, Ethics, Scientific, Authorization, Senegal, Burkina Faso
JOURNAL NAME:
Beijing Law Review,
Vol.14 No.3,
September
18,
2023
ABSTRACT: Introduction: Clinical trials issue is both legal and ethical. Pharmaceutical firms in developed countries are relocating more and more their tests in African continent, where lack of legislation weakens the fact to standardize clinical trials. Our objective was to make a retrospective comparative study on regulatory oversight of clinical trials in Burkina Faso and Senegal, from February 22th, to 1st of June 2016. Methodology: Data collection was performed by a literature review and interviews. Data analysis was done by comparing monitoring systems using indicators such as existence of a legal framework, mode of assessment and licensing, monitoring of clinical trials. Results: Clinical trials are regulated in Burkina Faso and Senegal. During the study, 34 authorizations were issued, and three sites were visited and one inspection made. The processing time of an application file is estimated at 110 days. As for Senegal, scientific evaluation by experts is not systematic. The processing time of a file is estimated at 40 days, and no inspection or site visit has been recorded. Conclusion: Burkina Faso regulatory oversight of clinical trials is implemented in accordance with GCP. Senegal hasn’t developed specific texts for clinical trials, and NEHR issues an ethical and scientific opinion. NRA has adopted ICH-GCP, without any mandate for assessing protocol. However, Burkina Faso’s current system combined with that of Senegal, could contribute to developing an effective model of regulatory oversight of clinical trials in West African Economic and Monetary Union, for public health benefit.