Abstract
Although some countries in sub-Saharan Africa have strengthened their systems and reached WHO GBT Maturity Level 3, important gaps remain. Addressing these gaps is critical for strengthening clinical research oversight and preparedness. This open letter highlights that ethics and regulatory systems are often fragmented. National ethics committees, regulatory authorities, and institutional review boards do not always have clear roles or strong coordination. Reviews can therefore be slow and inconsistent, especially for multi-site and multi-country trials. Joint inspections because there are few shared procedures, common guidelines, or formal agreement between regulators. Limited staff and funding worsen these problems and weaken oversight of complex, multi-site trials. Many clinical research sites are not well prepared for emergencies. They may struggle to quickly adapt their work and maintain safety and compliance when a public health crisis occurs, putting ongoing trials at risk. Digital systems for review and follow-up are also underdeveloped. Many committees and authorities lack integrated online submission platforms, linked databases, and pharmacovigilance e-portals. Safety reporting systems are often weak and scattered, and there is too little expertise in detecting and analysing safety signals. Links between ethics review, regulatory inspections, and safety monitoring are limited, making it harder to manage risks across the trial lifecycle. Information on the distribution and capacity of clinical trial sites is patchy, hindering rapid mobilisation during outbreaks. Training efforts are typically short term, fragmented, and poorly coordinated regionally, with insufficient emphasis on twinning and long-term mentorship to sustain skills. This affects the quality and timeliness of reviews, especially for complex, innovative, or multi-country protocols. Practical mechanisms to implement post-trial access commitments are often absent, which can erode participants’ trust. In response, this letter sets out recommendations and proposed actions for policymakers, regulators, research institutions, and ethics bodies to strengthen policies, systems, and day to day practices.