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Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative - Nature Medicine
Africa bears nearly 25% of the global burden of disease yet conducts only 2% of the world’s clinical trials and receives less than 2% of global health research funding1. In 2022, the World Health Assembly issued Resolution 75.8, calling for stronger clinical trial quality, coordination, and accountability worldwide. Delivering on that call requires more than additional resources: it requires knowing which structural deficit to fix first.
The TRACE initiative (Trial Regulation and Clinical Ethics Optimization)2, operating across Rwanda, Tanzania, Nigeria, Zimbabwe and Kenya in partnership with National Ethics Committees, Institutional Review Boards, and National Regulatory Authorities, offers an early answer. Across all five countries, the interventions producing the fastest, most measurable gains in trial readiness were not those that added technical capacity in isolation, but those that coordinated ethics and regulatory review into a single, parallel process.
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References
World Economic Forum. Healthcare Access in Africa: the Role of Clinical Trials https://go.nature.com/4c93gEe (accessed 4 June 2026).
TRACE Project. Trial Regulation and Clinical Ethics Optimization: Project Overview and Country Milestones https://traceclinicaltrialethics.com (accessed 4 June 2026).
WHO. Global Action Plan for Clinical Trial Ecosystem Strengthening (2023).
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Funding
This work was supported, in whole or in part, by the Gates Foundation. The conclusions and opinions expressed in this work are those of the author(s) alone and shall not be attributed to the Foundation. Under the grant conditions of the Foundation, a Creative Commons Attribution 4.0 License has already been assigned to the Author Accepted Manuscript version that might arise from this submission.
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Authors and Affiliations
King Faisal Hospital Rwanda, Kigali, Rwanda
Kara L. Neil
Centre for Impact, Innovation and Capacity Building for Health Information Systems and Nutrition (CIIC-HIN), Kigali, Rwanda
Jeanine Condo, Nathalie Umutoni, Ritah U. Mupende, Marie Angele Ikuzwe, Moise Ruhinda, Fantacy Twagira & Absolomon Gashaija
National Institute for Medical Research (NIMR), Dodoma, Tanzania
Obadia Kyetuza Bishoge
Moi University/Moi Teaching and Referral Hospital Institutional Research and Ethics Committee, Eldoret, Kenya
Peter Saula
Medical Research Council of Zimbabwe (MRCZ), Harare, Zimbabwe
Tendayi Kureya & Sithembile Ruzario
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), Boston, MA, USA
Barbara E. Bierer, Willyanne DeCormier Plosky & Sarah A. White
Barbara E. Bierer
Kenya Medical Research Institute - Scientific and Ethics Review Unit (KEMRI-SERU), Nairobi, Kenya
Enock Kebenei
National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria
Medicines Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe
Priscilla P. M. Nyambayo
Immunology Unit, Department of Laboratory, Diagnostic and Investigative Sciences, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe
Rutendo B. L. Gutsire
Rwanda Food and Drugs Authority (Rwanda FDA), Kigali, Rwanda
Alphonse Ndayambaje
Stella Ekallam, Elly Lefoll Kourany & David Mukanga
Rwanda National Research Ethics Committee (RNEC), Kigali, Rwanda
Vedaste Ndahindwa
National Commission for Science, Technology and Innovation (NACOSTI), Nairobi, Kenya
Teresia Nyawira
Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania
Damas Matiko
Consortia
on behalf of The TRACE Author Group
Kara L. Neil
, Jeanine Condo
, Obadia Kyetuza Bishoge
, Peter Saula
, Tendayi Kureya
, Barbara E. Bierer
, Willyanne DeCormier Plosky
, Sarah A. White
, Enock Kebenei
, Beno Nyam Yakubu
, Priscilla P. M. Nyambayo
, Rutendo B. L. Gutsire
, Sithembile Ruzario
, Alphonse Ndayambaje
, Nathalie Umutoni
, Stella Ekallam
, Ritah U. Mupende
, Marie Angele Ikuzwe
, Moise Ruhinda
, Fantacy Twagira
, Absolomon Gashaija
, Vedaste Ndahindwa
, Teresia Nyawira
, Damas Matiko
, Collins Mitambo
, Elly Lefoll Kourany
& David Mukanga
Corresponding authors
Correspondence to Kara L. Neil or Jeanine Condo.
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Competing interests
The authors have no competing interests to declare.
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About this article
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