It will specifically focus on the review and oversight of reported adverse events during clinical trials, enhance the efficiencies of the National Ethics Committees (NECs) and National Regulatory Authorities (NRAs), and equip them with the skills and knowledge necessary for improved operations during outbreaks and epidemics.
The aim of AccessAfrica 2 is to:
- Increasing the regulatory and ethics capacities of NRAs, NECs, and IRBs for the review, approval, and oversight of clinical trials in Ethiopia and Uganda.
- Strengthening the links between ethics and regulatory functions by establishing collaborative relationships between NEC, NRA and local IRB, and communication among the related actors.
- Build capacity for increased research leadership through collaboration with the Eastern Africa Consortium for Clinical Research (EACCR).
Background
Clinical trials in Sub-Saharan Africa (SSA), including vaccine development for poverty-related diseases, are increasing, but regulatory and ethical oversight lags behind. Specific gaps exist in skills and knowledge related to providing adequate regulatory oversight, ethical review, and pharmacovigilance. The efficiency of the regulatory and ethical review processes remains poor, often requiring a prolonged period before approvals are granted.
Consequently, there is dissatisfaction within the research community, particularly regarding the time interval from submission to decision. Furthermore, feedback from a review process involving multiple regulatory bodies can result in unfavorable timelines for both ethical and regulatory approvals. Again, multiple review processes may produce contradictory results and decisions from the respective regulatory authorities (RAs), underscoring the importance of developing a joint working mechanism.
Access Africa 2 aims to improve ethical review and regulatory capacity for clinical trials in two Sub-Saharan Africa (SSA) countries, with a specific focus on the review and oversight of reported adverse events during clinical trials, improving the efficiencies of the NECs and NRAs, and equipping them with the skills and knowledge needed for improved operations during outbreaks and epidemics.
AccessAfrica: Improving post-trial access in Africa
Read more about Acess Africa2's sister project AccessAfrica: Improving post-trial access in Africa (Institute of Health and Society, UiO). This is an EDCTP2 funded research project, that aims to improve post-trial access arrangements in clinical trials in sub-Saharan Africa.