In this episode, we go behind the scenes of clinical trial start-up to explore what happens before the first participant is enrolled.
ACRN CEO Dr Tariro Makadzange and Regulatory Affairs Officer Knowledge Ushamba discuss the regulatory, ethics, and operational systems needed to support high-quality clinical research in Africa.
The conversation highlights the importance of ethics review, regulatory approvals, site readiness, contracts, import permits, documentation, and data quality. It also examines why trial activation can take longer than expected, how fragmented and sequential processes create delays, and what can be done to make research systems more predictable and efficient.
Key topics include parallel review, central IRBs, common application forms, regulatory harmonisation, and the need for clear country-level regulatory playbooks. The episode also explores why improving trial start-up timelines matters for patients, researchers, policymakers, and Africa’s competitiveness in global and locally led research.
Listen to the full episode: Optimising regulation and ethics in research