SCALING UP CAPACITY TO SUPPORT CONDUCT OF CLINICAL TRIALS IN THE EAST AFRICAN COMMUNITY

The East African Community (EAC) has experienced significant increase in volume and complexity of clinical research driven by epidemics of emerging and remerging infectious diseases such as HIV, Ebola and COVID-19, requiring expertise in scientific and ethical review and conduct of research and a robust and pragmatic research regulatory framework.

The overall goal is to strengthen scientific and ethics capacity in EAC for high quality research review, conduct and oversight, at international standards. The specific objectives are: 1.

To train NRRA personnel, REC members, researchers and clinicians on scientific and ethics review and conduct of research with emerging and complex study designs including adaptive platform trials 2. To train NRRA personnel and REC members on oversight, monitoring and pharmacovigilance of clinical trials and 3.

To train NRRA personnel, REC and research administrators on personal effectiveness and leadership skills (PELS) to manage the increasingly complex research processes.

Methods: We will implement this project within a consortium of research scientists from the six partner states collaborating with the EU partner, with the East African Health Research Commission as the strong nucleus for coordination and dissemination of results.

The project will be hosted at the Infectious Diseases Institute (IDI), where within a previous NIH funded program (5G11 TW011309-01) we built capacity for REC members, researchers and REC administrators for 7 RECs in Uganda, with significant improvement in knowledge, PELS, quality and turnaround time of research review and researcher satisfaction.

This proposal fits within the scope of GH-EDCTP3-2022-01-05 call, whose aim is to strengthen clinical research capacity and improve efficiency of the regulatory environment for effective development, delivery and uptake of new and improved safe health technologies and rapid response to emerging epidemics guaranteeing international standards and attainment of SDG3.