Project Objectives
The purpose of this training is to acquire specific skills, knowledge and experience necessary for conducting and implementing clinical trials study which could be obtained either through course works and/or practical attachments at host institutions.
Project Summary
Clinical trials are a critical pillar of modern evidence-based medicine, serving as a foundation for clinical decision-making and the development of innovative therapeutic interventions. However, Ethiopia has seen very limited clinical research activity to date. The lack of infrastructure, regulatory frameworks, and trained personnel presents persistent challenges. To address these gaps, strategic partnerships among academia, industry, regulatory bodies, and international sponsors are essential. My participation in the EDCTP-funded Clinical Research and Product Development Fellowship has been a significant step toward this goal.
As part of this fellowship, I successfully completed a structured placement at the Clinical Trials Facility (CTF) of the KEMRI-Wellcome Trust Research Programme (KWTRP) in Kilifi, Kenya. The training focused on practical exposure and advanced capacity-building in Good Clinical Practice (GCP), trial protocol development, ethical and regulatory submissions, data management, pharmacovigilance, trial monitoring, and quality assurance systems in clinical trial settings. The experience significantly enhanced my competencies in clinical research operations and regulatory requirements and positioned me to lead clinical trial implementation in Ethiopia.
As a full Professor of Pharmaceutical Analysis and Regulatory Affairs at Jimma University—serving both at the School of Pharmacy and as the founding Director of the Jimma University Laboratory of Drug Quality (JuLaDQ)—I have been actively involved in pharmaceutical R&D, regulatory affairs, and clinical research. My research focuses on drug development at molecular and preclinical levels, pharmaceutical regulatory affairs, and quality assurance. Jimma University has established several specialized research centers—including the Molecular Biology, Mycobacteriology, and Tropical and Infectious Diseases Research Centers—that together provide a robust foundation for clinical and pharmaceutical research.
As an outcome of the fellowship, several key advancements have been initiated and/or strengthened:
• Institutional Capacity Building: I am leading drug research and development at Jimma University, aligning with international GxP standards.
• Human Resource Development: I am currently supervising a number of Master’ s students in pharmaceutical quality assurance and regulatory affairs, clinical pharmacy, and PhD in Pharmaceutical Sciences to support long-term training and capacity-building in clinical research.
• Collaborative Networks: Through the fellowship, I established active professional links with researchers and clinical trialists at KWTRP and beyond, laying the foundation for future collaborative projects in the region.
• Applied Research Contributions: I am now better equipped to lead the design, implementation, and oversight of clinical trials, especially those focused on neglected infectious diseases and priority public health concerns in Ethiopia and sub-Saharan Africa.
In conclusion, the EDCTP fellowship and placement at KWTRP/CTF have been pivotal in advancing my career as a clinical researcher and in supporting the strategic objectives of Jimma University to become a hub for clinical research and regulatory science in Ethiopia. The skills and knowledge gained will directly contribute to strengthening research systems, improving access to ethical and high-quality trials, and ultimately promoting better health outcomes across the region.
