Periodic Reporting for period 1 - ACCESSAFRICA2 (Strengthening Clinical Trial Regulatory and Ethical review Oversight in East Africa)
Reporting period: 2023-07-01 to 2024-12-31
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).
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).
WP1 focus on developing a plan and strategy for communication with a range of stakeholders, setup and launch the communication platform - Webpage, and to develop a schedule and structure to ensure communication of project developments, outcomes and knowledge gained with consortium partners. Main achievements: setup and launched the project webpage; developed project word and power point templates for reporting; developed a communication channel via Microsoft Teams, setup a bimonthly zoom meetings for the work package leaders for to update on project progress and outcomes; regular coordination and management of the project; regular reporting to the project Officer.
WP2 focus on improving regulatory and ethical review and oversight of clinical trials. Main achievements: recruitment of 2 regulatory officers; safety monitoring system developed; joint inspection conducted; desk review of RAs and IRBs conducted; clinical trial operational manual for NDA developed.
WP3 focus on strengthening linkages between regulatory authorities and ethics review committees. Main achievements: joint inspection guidelines developed and approved; final proposal for COVID-19 survey developed; guidelines and frameworks to Ethiopia partners developed and rolled out.
WP4 focus on increasing capacity for research leadership in Sub-Saharan Africa. Main achievements: Training manual leadership developed
WP2 focus on improving regulatory and ethical review and oversight of clinical trials. Main achievements: recruitment of 2 regulatory officers; safety monitoring system developed; joint inspection conducted; desk review of RAs and IRBs conducted; clinical trial operational manual for NDA developed.
WP3 focus on strengthening linkages between regulatory authorities and ethics review committees. Main achievements: joint inspection guidelines developed and approved; final proposal for COVID-19 survey developed; guidelines and frameworks to Ethiopia partners developed and rolled out.
WP4 focus on increasing capacity for research leadership in Sub-Saharan Africa. Main achievements: Training manual leadership developed
AccessAfrica 2 has the potential to impact several areas, such as;
1) Strengthened overview of clinical trails: the project's activities will improves regulatory and ethical review and oversight of clinical trials, improves the safety of research participants and the quality of clinical trials done in Uganda, and Ethiopia
2) Joint review guidelines and framework: This it will improved coordination between regulatory authorities and research ethics committees, along with shared guidelines and frameworks within the EACCR, will strengthen research ethics and regulatory oversight in the region
3) Pharmacovigilance exchange visit: Will enhance the ability of the regulatory bodies and ethics committees to offer better oversight and review of clinical trials
4)The project outcomes: Will improve the efficiency of regulatory authorities and ethics review committees clinical trial oversight by significantly reducing the time required for approval processes. This will have a positive impact on the time taken to complete clinical trials and the associated budgets
1) Strengthened overview of clinical trails: the project's activities will improves regulatory and ethical review and oversight of clinical trials, improves the safety of research participants and the quality of clinical trials done in Uganda, and Ethiopia
2) Joint review guidelines and framework: This it will improved coordination between regulatory authorities and research ethics committees, along with shared guidelines and frameworks within the EACCR, will strengthen research ethics and regulatory oversight in the region
3) Pharmacovigilance exchange visit: Will enhance the ability of the regulatory bodies and ethics committees to offer better oversight and review of clinical trials
4)The project outcomes: Will improve the efficiency of regulatory authorities and ethics review committees clinical trial oversight by significantly reducing the time required for approval processes. This will have a positive impact on the time taken to complete clinical trials and the associated budgets