Abstract / Summary
Background Clinical trials and related health research in sub-Saharan Africa continue to expand in volume and complexity, increasing the need for strong and responsive research ethics oversight, regulatory reviews, and pharmacovigilance systems. The ASCEND project was implemented in Tanzania Mainland and Zanzibar from November 2020 to December 2023 to support these functions through capacity development and system-strengthening activities. Objective To describe the implementation approach and documented outputs of the ASCEND project as a case study focusing on operational processes that may inform similar initiatives. Approach We compiled and synthesized project documentation produced during implementation, including training materials, activity reports, system development records, and consortium deliverables. We summarized implementation components and verified output counts across records. Outputs The project developed and delivered training packages for clinical trial protocol review and Good Clinical Practice inspection and trained 30 clinical trial protocol reviewers or assessors and 25 inspectors, including on-the-job inspection exposure for Zanzibar Food and Drug Authority staff. Assessors’ mean test scores rose from 61 to 80 out of 100. Nineteen early- and mid-career researchers and 50 trainers from institutional ethics committees were trained on research ethics and clinical trial-related topics. Digital tools from an earlier project were operationalized or upgraded to support ethics review workflows and safety reporting, including an online serious adverse event reporting module and linked electronic submission and review workflows. A Pharmacovigilance Community Engagement Model was developed and applied to sensitization activities in both settings. Networking forums were convened to support interactions among researchers, institutional review boards, and regulators. Conclusion This case study documents the implementation of a multicomponent capacity development initiative that combines training, digital tools, community engagement, and stakeholder networking. The experience highlights practical considerations for similar programs, including institutional ownership, integration of electronic tools into routine workflows, and early planning for sustainability within existing structures.