Title : Strengthening clinical trial capacity in Ethiopia: Challenges, lessons learned, and future directions

Background: Clinical trials are essential for developing safe and effective interventions to improve health outcomes. Although Africa accounts for approximately 19% of the world's population and bears a substantial burden of global disease, only a small fraction of clinical trials are conducted on the continent. Ethiopia, the second most populous country in Africa, has significant potential for clinical research but continues to contribute relatively few clinical trials.

Methods: A review of published literature, policy documents, and reports was conducted to identify operational, regulatory, infrastructural, and human resource challenges affecting clinical trial implementation in Ethiopia. Key lessons learned and future opportunities for strengthening national clinical trial capacity were also examined.

Results: Major challenges include limited research infrastructure, shortages of certified laboratories and trained research personnel, inadequate funding, lengthy ethical and regulatory review processes, and difficulties in participant recruitment and retention. Dependence on external funding and limited institutional support further constrain research growth. However, important progress has been achieved through the establishment of the Ethiopian National Clinical Trial Network (CTN-ET), the development of regulatory guidelines by the Ethiopian Food and Drug Authority (EFDA), and investment in research training and mentorship programs. Recent clinical research initiatives highlight the value of multidisciplinary collaboration, community engagement, and decentralized research approaches.

Conclusion: Strengthening clinical trial capacity in Ethiopia requires sustained investment in infrastructure, workforce development, regulatory efficiency, and data management systems. Expanding implementation of the National Clinical Trial Roadmap and leveraging CTN-ET can enhance Ethiopia's contribution to global clinical research. Addressing existing gaps will improve the country's ability to generate high-quality evidence and support equitable access to innovative health interventions.

Keywords: Clinical trials; Ethiopia; research capacity; regulatory challenges; global health

To be updated shortly..