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. 

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

Pharmacovigilance Situation in Sierra Leone in the Light of the Ebola Crisis

Clinical trials during public health emergencies of novel medical products such as therapeutics and vaccines in resource-limited settings are daunting due to the limited capacity for regulatory assessment. Regulating clinical trials during the Ebola outbreak in Sierra Leone required expedited evaluation to identify medical products that could be promptly introduced to combat the epidemic in the absence of approved treatment or prevention. This article explored the decisions taken by the Pharmacy Board of Sierra Leone through its Expert Committee on Medicine Safety and Clinical Trials regarding clinical trials oversight during the Ebola epidemic and the lessons learned. This independent expert committee assessed and provided scientific opinions to the Pharmacy Board of Sierra Leone to inform approval of all clinical trials within 10-15 working days. We also requested for assisted review from the African Vaccine Regulatory Forum and support from the US Food and Drug Administration through a unilateral recognition and reliance memorandum of understanding. In addition, the Agency-ensured structures and systems were in place for reporting and reviewing adverse events and serious adverse events, management of biological samples, submission and review of progress reports, and good clinical practice inspections. Unfortunately, the Ebola epidemic revealed many weaknesses in the country's clinical trials regulatory structure and processes. Government and partners should further offer more resources to build the clinical trial structures and systems so that the Agency will be better poised to handle future public health emergencies. 

/pdf/regulating-clinical-trials-in-a-resource-limited-setting-1tmomewc.pdf

Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone

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Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone