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Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative

Publication

Published on: September 7, 2026

Published in: Nature Medicine

Description: The TRACE Author Group, led by Kara L. Neil and Jeanine Condo and including Barbara Bierer, Willyanne DeCormier Plosky, and Sarah White of the MRCT Center, published “Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative” in Nature Medicine. The authors report early results from the TRACE Project in Kenya, Nigeria, Rwanda, Tanzania, and Zimbabwe, where coordinating ethics and regulatory review into a single, parallel process drove the fastest gains in trial readiness. In Zimbabwe, a joint electronic platform linking the medicines regulator and the national ethics review function reduced approval times by at least 20%. The authors recommend that parallel review become standard practice across African clinical trial systems.

Neil, K.L., Condo, J. & on behalf of The TRACE Author Group. Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative. Nat Med (2026). https://doi.org/10.1038/s41591-026-04645-7