The project has yielded significant advancements in research capacity-building across the East African Community (EAC) partner states, surpassing initial expectations in several key areas.
Enhanced Knowledge and Competency in Emerging and Complex Study Designs (ECSDs): Observed knowledge shift from 62% to 80% (pre-test vs. post-test) was observed among trained National Research Regulatory Agency (NRRA) personnel, Research Ethics Committee (REC) members, researchers, and clinicians.
Qualitative feedback from participants indicated a deepened understanding of adaptive platform trials and other complex designs, improving their ability to critically review clinical trial protocols.
The curriculum could now serve as a benchmark for future regulatory and ethical training programs in the East African Community (EAC)
Training on clinical trials monitoring and pharmacovigilance resulted in a knowledge gain from 60% to 79%, equipping NRRA personnel, REC members, and clinical trial monitors with essential clinical trial monitoring skills and knowledge. This enhanced expertise supports more rigorous monitoring of clinical trials, aligning with international standards for ethical and scientific integrity.
The Personal Effectiveness and Leadership Skills (PELS) training led to a knowledge shift from 64% to 85%, demonstrating improved leadership capacities among NRRA, REC, and research administrators.
Participants reported greater confidence in managing complex research processes, improving decision-making and operational efficiency in regulatory institutions.
The standardized curricula on ECSDs, clinical trial monitoring, and PELS can be adopted by national regulatory agencies and academic institutions, ensuring long-term capacity strengthening.
Expanding the training to French-speaking stakeholders in Burundi and beyond could further enhance regional harmonization.
There is a need to explore the long-term impact of these trainings on regulatory decision-making and research oversight.
Future research could assess the application of training knowledge in real-world clinical trial approvals and monitoring processes.
Strengthening cross-border collaboration between NRAs and RECs in the EAC will facilitate a harmonized regulatory framework for clinical research oversight.
Engagement with global regulatory bodies (e.g. WHO, EMA, FDA) can ensure alignment with best practices and international ethical standards.
Expanding the IDI e-learning platform to provide continuous professional development (CPD) certification could increase accessibility and scalability of training.
Developing multi-language versions of the curricula (English, French, Swahili) would further enhance inclusivity across diverse stakeholder groups.
