Strengthening Clinical Trial Regulatory and Ethical review Oversight in East Africa

There is an increase in the number of drug development clinical trials conducted in Sub-Saharan Africa (SSA), including vaccine development studies for poverty-related diseases (PRDs) underway in SSA. These increases have not been matched with increase in regulatory support and ethical review for such studies in SSA.

Specific gaps exist in skills and knowledge in providing adequate regulatory oversight, ethical review and pharmacovigilance for such studies, efficiency of the regulatory and ethical review processes.

With sequential processes of review requiring a prolonged period before approvals are granted, there is dissatisfaction with the the time interval from submission to decision, within the research community.

Additionally, mechanisms for reporting adverse events to both the ethics committees and national regulators are not well developed.

The Aim of AccessAfrica 2 is to improve ethical review and regulatory capacity for clinical trials in two Sub-Saharan Africa (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 oversight for novel research designs.AccessAfrica 2 is a embedded in the Eastern Africa Consortium for Clinical Research (EACCR), and EDCT funded network, and is continuation of AccessAfrica project which was funded by EDCTP.

We propose to address the identified gaps through the three objectives and four work packages.

We will establish a consensus driven consortium with partners leveraging each others strength to achieve the objectives.

We propose to incorporate the AVAREF guidelines in the regulatory and ethical review guidelines of the partners, and work with the Kenya Pharmacy and Poisons board to improve the pharmacovigilance for research capacity in the partner countries.