Clinical Trial Safety Surveillance in Africa: Experts' Perspectives on Current Practices and Opportunities

Clinical trial (CT) safety surveillance is critical to protecting participants and ensuring reliable evidence on the safety and efficacy of new medical products. This is especially relevant in Africa, where CT activity remains limited, regulatory maturity varies, and drug safety surveillance systems are under-resourced despite considerable demographic advantages and genetic and cultural diversity. Pre-licensure safety monitoring is a vital yet underdeveloped element of the research ecosystem, and the absence of a regional repository for safety data constrains early detection of risks, particularly in multi-country trials. To assess the current state of CT safety surveillance in Africa, a landscape analysis of the systems for clinical trial safety data reporting, collation, and analysis was conducted. Expert perspectives were synthesized to describe existing practices, identify key gaps, and propose opportunities for strengthening systems. Findings revealed limited regulatory capacity, limited drug safety monitoring expertise, and inadequate resources for causality assessment and aggregate data analysis. Despite these challenges, opportunities exist to strengthen CT safety surveillance through digitization of reporting systems, harmonization of serious adverse event forms, regional collaboration, and capacity building for strengthening the ecosystem. Experts emphasized the need for collaboration among regulators of member states, availability of electronic CT management platform in member states and a regional pre-licensure safety data repository to enable timely evidence generation, support member states, and ensure appropriate linkages between pre-licensure and post-market surveillance. Strengthening CT safety surveillance is critical for safeguarding participants, promoting ethical research, and enhancing Africa's role in global clinical research. The results of this landscape analysis provide a roadmap for building a coordinated model for pre-licensure safety monitoring across the continent.