Sub-Saharan Africa (SSA) has seen a surge in drug and vaccine trials, particularly for diseases like malaria and other poverty-related illnesses. However, this increased research activity is hampered by inadequate regulatory support and ethical review capacity. SSA faces significant gaps in the skills and knowledge needed for effective regulatory oversight, ethical review, and pharmacovigilance, leading to inefficient and prolonged approval processes. This inefficiency, coupled with multiple, sometimes conflicting reviews from various regulatory bodies, creates dissatisfaction within the research community. These bodies often lack the expertise to review complex studies and require capacity building to ensure participant safety and welfare. Furthermore, mechanisms for adverse event reporting and joint oversight frameworks between ethics committees and national regulators are underdeveloped. The COVID-19 pandemic has further strained these systems, with RECs and RAs needing capacity building to handle complex study designs and emerging ethical challenges. These issues underscore the urgent need to strengthen the capacity of National Regulatory Authorities (NRAs) and National Ethics Committees (NECs) across SSA.
The primary objective of AccessAfrica 2 is to improve ethical review and regulatory capacity for clinical trials in two SSA countries, with specific focus on the review and oversight of reported adverse events during clinical trials, improve efficiencies of the NECs and NRAs, and equip them with skills and knowledge for improved operations during outbreaks and epidemics.
AccessAfrica 2 has outlined specific objectives to accomplish this, including
1) To increase the regulatory and ethics capacities of NRAs, NECs, and IRBs for the review, approval, and oversight of clinical trials in Ethiopia and Uganda. This will be through a needs assessment process for these institutions, to identify gaps and plan actions.
2) To Strengthen the links between ethics and regulatory functions by establishing collaborative relationships between NEC, NRA and local IRB, and communication among the related actors.
3) To build capacity for increased research leadership through collaboration with the Eastern Africa Consortium for Clinical Research (EACCR).
