Building National Foundations to Support Clinical Research in Africa

Q&A with TRACE Project Team

The TRACE (Trial Regulation and Clinical Ethics Optimization) Project is a multi-country African initiative launched in 2025 to strengthen and harmonize clinical trial ethics and regulatory oversight. The below Q&A with Elly Kourany-Lefoll and Collins Mitambo of the TRACE Project team details its work with national ethics committees, regulators, and research institutions to make review systems more transparent, predictable, and efficient through capacity building, policy and standard operating procedures (SOP) harmonization, digitalization, sustainable financing models, and stronger coordination with regional and continental frameworks. TRACE has been active in Nigeria, Rwanda, Tanzania, and Zimbabwe, and has recently expanded into Kenya.