Between Statutes and Practice: Regulatory Capacity for Clinical Trials in The Gambia within the ECOWAS Regional Context

Abstract

The global expansion of clinical research has heightened the importance of strong national regulatory systems capable of ensuring ethical conduct, scientific validity, and participant safety. While West Africa has become an increasingly important region for clinical trials, regulatory capacity across the region remains uneven, and small states such as The Gambia are underrepresented in regulatory scholarship. This desk-based review assesses the regulatory capacity for clinical trial oversight in The Gambia through a comparative analysis within the ECOWAS region. Drawing on national legislation, regulatory guidelines, regional harmonisation frameworks, and international benchmarking tools, the study examines legal authority, institutional capacity, approval processes, ethics oversight, and pharmacovigilance systems. Comparative insights from Ghana, Nigeria, and Senegal highlight both shared challenges and divergent regulatory trajectories. The analysis shows that although The Gambia has established foundational regulatory frameworks aligned with international standards, significant operational and capacity-related gaps persist. The study underscores the importance of regulatory reliance, regional harmonisation, and targeted capacity strengthening in advancing regulatory readiness in small regulatory systems.

Conclusion: This review demonstrates that strengthening regulatory readiness in The Gambia will depend less on new legislation and more on institutional capacity development, regional collaboration, and effective use of reliance mechanisms. Addressing these priorities is essential to safeguarding research participants and enhancing the country’s role in global clinical research.