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The TRACE Project (Trial Regulation and Clinical Ethics Optimization) is proud to announce the formal inclusion of Kenya into its multi-country initiative, which is already being implemented in Tanzania, Nigeria, Rwanda, and Zimbabwe. This expansion aims to strengthen and align Kenya’s clinical trial oversight systems with regional best practices.
The Kenyan expansion is a collaborative effort between the National Commission for Science, Technology and Innovation (NACOSTI), the Pharmacy and Poisons Board (PPB), the Kenya Medical Research Institute (KEMRI), and Moi Teaching and Referral Hospital / Moi University College of Health Sciences – Institutional Scientific and Ethical Review Committee (MTRH/MU-ISERC). Together, these institutions are streamlining clinical trial review processes to ensure rapid delivery of research findings without compromising participant safety.
Key technical milestones for Kenya include:
- Implementation of parallel review processes between ethics committees (ISERC) and the PPB, supported by revised Standing Operating Procedures (SOPs) and operational workflows to reduce duplication and accelerate clinical trial approvals.
- Enhancement and integration of digital systems to support end-to-end clinical trial application and review processes, including improved data capture, workflow management, and system interoperability.
- Strengthening of reviewer capacity and institutional performance, through structured training programs, standardized review tools, and continuous professional development for ethics and regulatory reviewers.
- Advancement of Institutional Review Board (IRB) accreditation and oversight frameworks, in collaboration with NACOSTI, to ensure consistent quality and accountability in clinical trial review processes.
- Optimization of review timelines, with a target to reduce protocol review duration to under 60 days through process improvements and better coordination across institutions.
About TRACE Project: The TRACE Project is a multi-country initiative dedicated to improving the transparency, predictability, and efficiency of clinical trial ethics and regulatory reviews. By leveraging digital tools and collaborative frameworks, TRACE aims to accelerate the delivery of life-saving medical interventions.
Recent Progress Across Africa
The TRACE Project continues to transition from identifying systemic gaps to implementing high-level governance reforms and digital infrastructures across its partner countries. Recent milestones include:
- Launch of the TRACE Bioethics Forum: This quarterly series provides a platform for National Research Ethics Committees (NRECs) and IRBs to address complex ethical dilemmas. The inaugural session, co-led by Rwanda, focused on ethics during the 2024 Marburg Outbreak response.
- Digital Transformation in Zimbabwe and Rwanda: Zimbabwe has made strong progress in developing its Clinical Trials and Protocol Processing System, an integrated digital platform supporting end-to-end submission, screening, and review of research protocols. The system has been demonstrated to both the Medicines Control Authority of Zimbabwe (MCAZ) and the Medical Research Council of Zimbabwe (MRCZ), with user training materials already developed. It is currently being refined through ongoing stakeholder engagement. Meanwhile, Rwanda has finalized technical specifications for a National Digital Ethics Review System to enable parallel submissions with the Rwanda Food and Drugs Authority (Rwanda FDA).
- Review of the SOPs in Rwanda and the National Code of Health Research Ethics in Nigeria. The TRACE Project recently supported the review of SOPs for the Rwanda National Ethics Committee in Rwanda to ensure alignment with current ethical standards, regulatory requirements, and international best practices. The revised SOPs will improve oversight of clinical research and facilitate timely review of research applications.In Nigeria, the review of the Code of Ethics is nearing completion, with expected refinements to reliance frameworks and clinical trial review mechanisms. Plans are also underway to enhance the National Health Research Ethics Committee digital platform to support more efficient submission and review workflows.
- Regulatory Advances in Tanzania: The National Institute for Medical Research (NIMR) has continued to strengthen clinical trial regulatory and ethics systems through targeted capacity-building activities. These efforts have included training and mentorship sessions for regulators, ethics committee members, and research personnel aimed at improving understanding of clinical trial review processes, timelines, and good regulatory practices. Tanzania has reached a key milestone with the commencement of the drafting process for the National Traditional Medicine Research Guidelines. Currently under development, these guidelines aim to bridge regulatory gaps and align local research with international ethical standards.
- Looking ahead, the TRACE consortium will convene in Harare at the beginning of June for its second face-to-face meeting to review project progress and coordinate the next phase of regional implementation.
