CAPACITY 2023 · CONSORTIUM FOR DEVELOPING REGULATORY CAPACITY FOR CLINICAL TRIALS USING GENE THERAPY PRODUCTS AND STRENGTHENING PHARMACOVIGILANCE IN THE CONDUCT OF CLINICAL TRIALS IN EAST AFRICA

Gene therapy advancements have shown promise in treating chronic conditions like HIV and Sickle cell Anaemia and have the potential to greatly reduce the burden of disease in Sub-Saharan Africa which is plagued with a double burden of communicable and non-communicable diseases. These treatments have the potential to reduce the burden of disease for the populations for which they are targeted and the cost of treatments for governments. In Sub-Saharan Africa, there are largely no or unclear regulatory frameworks for clinical trials using Gene Therapy products. As pioneers setting up frameworks for regulatory oversight of clinical trials using Gene and cell-based therapy products, Uganda and Tanzania will be able to share this knowledge through regional platforms to support other countries in the region to put in place similar regulatory frameworks. Additionally researcher workshops and course developed on Gene Therapy Products will build capacity among researcher, regulators and the public.Pharmacovigilance in clinical trials for safety of trial participants and to accurately characterize the safety profile of the drug for the targeted patient population. Safety monitoring in clinical trials in the region, currently faces challenges associated with health system challenges, investigator awareness, poverty and limited access to diagnostic tools. Additionally, there is limited investigator awareness of of their responsibility to the patients with regard to monitoring and treating and accurate reporting of serious adverse events during clinical trials. The results of this project will also provide a basis to sensitize investigators/sponsors and engage policymakers on the requisite health systems reforms to create a safe environment for the conduct of clinical trials with the ultimate goal of accelerating research, registration and access to these new medicine technologies.