ACCESSAFRICA2

The challenge

Although still relatively low, an increasing number of clinical trials are being conducted in sub-Saharan African countries. There are still several barriers that limit further expansion, including the typically lengthy time taken for regulatory review and limited infrastructure for monitoring safety during clinical trials.

The first ACCESSAFRICA project, funded by the EDCTP2 programme, sought to build ethics review and regulatory capacity in Ethiopia and Uganda, with a particular focus on ensuring that participants in clinical research gained access to new interventions at the end of trials. The project was undertaken within the framework of the EDCTP regional Network of Excellence, the East African Consortium for Clinical Research (EACCR).

The project

Building on the partnerships established in the first project, the EDCTP3 Global Health-funded ACCESSAFRICA2 project is working to further develop ethics review and regulatory capacity in Ethiopia and Uganda. The project has a particular focus on pharmacovigilance for clinical trials, improving operational efficiency and coordination, and research during outbreaks and epidemics.

Needs assessments are being carried out in each country to identify capacity gaps and to inform national capacity-development plans. For pharmacovigilance, the project is developing updated guidelines and providing training, drawing on the resources of the African Vaccine Regulatory Forum (AVAREF). This will support coordinated reporting of adverse events to both ethics review and regulatory bodies. The project will also draw on the expertise of the Kenyan Pharmacy and Poisons Board, a regional centre of regulatory excellence (RCORE).

Efforts are also being made to strengthen collaborations between national regulatory agencies, national ethics committees and institutional review boards. This will create opportunities for coordinated activities, such as joint reviews of applications and site visits, reducing duplication of efforts. 

In addition, short-course training will also be provided to at least 30 early- and mid-career researchers to build research leadership capacity. Training will also be provided to institutional review board members, leveraging the EACCR network. The project will also provide an opportunity to roll out the guidance on post-trial access that was developed during the first ACCESSAFRICA project.

Impact

The ACCESSAFRICA2 project will further strengthen ethics review and regulatory capacity in Ethiopia and Uganda. It will:

• Build capacity in pharmacovigilance, providing a stronger foundation for safety monitoring during clinical studies.
• Strengthen collaborations between ethics review and regulatory bodies, improving efficiencies and reducing application assessment times.
• Enable national regulatory authorities to enhance their maturity level.

Over the longer term, the project will create a sustainable subregional network through which further capacity building can be embedded, enabling more clinical studies to be conducted safely and efficiently in the two countries and elsewhere in East Africa.