Project description
Increasing clinical trial capacity in East Africa
Due to the emergence of infectious diseases such as HIV, Ebola and COVID-19, the East African Community (EAC) is in need of expertise in scientific and ethical review, as well as a robust research regulatory framework. The EU-funded SCALE-IT project aims to enhance the EAC’s capacity for high-quality research review, conducting research, and overseeing it at international standards. This project will provide training in scientific and ethical principles, as well as in conducting research with emerging and complex study designs. It will also offer training in personal effectiveness and leadership skills to help manage the increasing complexity of research processes. The Infectious Diseases Institute in Uganda will serve as the host for this project, while the East African Health Research Commission will coordinate SCALE-IT.
Objective
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.
Fields of science
Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinator
75019 Paris
France