By Juliet Umeh

Kenya has formally joined the TRACE Project, a multi-country initiative aimed at improving the efficiency, transparency and coordination of clinical trial ethics and regulatory review systems across Africa.

The expansion of the Trial Regulation and Clinical Ethics Optimization, TRACE, Project is expected to strengthen Kenya’s clinical trial oversight framework through faster review timelines, digital transformation and improved collaboration among regulatory institutions.

The project is already being implemented in Nigeria, Tanzania, Rwanda and Zimbabwe.

The Kenyan rollout is being coordinated through a collaboration involving the National Commission for Science, Technology and Innovation, NACOSTI, the Pharmacy and Poisons Board, PPB, the Kenya Medical Research Institute, KEMRI, and the Moi Teaching and Referral Hospital/Moi University College of Health Sciences Institutional Scientific and Ethical Review Committee, MTRH/MU-ISERC.

According to the organisers, the initiative is designed to streamline clinical trial review processes while maintaining participant safety and ethical standards.

A statement by the TRACE Project explained that one of the major reforms in Kenya would be the implementation of parallel review processes between ethics committees and the PPB.

The statement noted that the move would be supported by revised Standard Operating Procedures, SOPs, and operational workflows to reduce duplication and accelerate approvals for clinical trials.

“The implementation of parallel review processes between ethics committees and the PPB will help reduce duplication and accelerate clinical trial approvals without compromising participant safety,” the statement said.

TRACE also disclosed that Kenya would enhance and integrate digital systems to support end-to-end clinical trial application and review processes.

According to the project team, the digital upgrades will improve data capture, workflow management and interoperability among institutions involved in research oversight.

The project further stated that reviewer capacity and institutional performance would be strengthened through structured training programmes, standardised review tools and continuous professional development for ethics and regulatory reviewers.

On oversight and accountability, TRACE said efforts were ongoing to advance Institutional Review Board accreditation and strengthen regulatory frameworks in collaboration with NACOSTI.

The initiative is also targeting a reduction in protocol review timelines to less than 60 days through improved coordination and process optimisation.

Speaking on broader continental progress, TRACE highlighted the launch of the TRACE Bioethics Forum, a quarterly platform created for National Research Ethics Committees and Institutional Review Boards to address emerging ethical challenges in clinical research.

According to the consortium, the inaugural forum session, co-led by Rwanda, focused on ethical issues surrounding the 2024 Marburg outbreak response.

The project also pointed to digital transformation efforts in Zimbabwe and Rwanda.

It stated that Zimbabwe had made significant progress in developing an integrated Clinical Trials and Protocol Processing System to support end-to-end submission, screening and review of research protocols.

In Rwanda, TRACE disclosed that technical specifications had been completed for a National Digital Ethics Review System aimed at enabling parallel submissions with the Rwanda Food and Drugs Authority.

The consortium further noted that Nigeria was nearing completion of the review of its National Code of Health Research Ethics, with expected improvements in reliance frameworks and clinical trial review mechanisms.

It added that plans were underway to upgrade the digital platform of the National Health Research Ethics Committee to support more efficient submission and review workflows.

TRACE also announced that its consortium members would meet in Harare in June for their second face-to-face meeting to assess project progress and coordinate the next phase of implementation across partner countries.