The conduct of clinical trials requires competent ethics committee and regulatory authorities that can review clinical trial applications and monitor processes independently and efficiently ensuring the safety of clinical trial participants, and the integrity and reliability of the generated data. Our aim is to achieve ethics and regulatory excellence and harmonization in sub-Saharan Africa in clinical trial oversight.
The RER-CTO consortium consists of a group of well reputable clinical trial researchers, regulatory authorities, ethics committees, universities and research institutes in Ethiopia, Tanzania, Norway, and Sweden. Our aim is to achieve ethics and regulatory excellence and harmonization in sub-Saharan Africa in clinical trial oversight (CTO) by improving the legal and policy framework by identifying gaps and making recommendations, improving regulatory and research ethics oversight capacity and capability by digitalising the clinical trial oversight systems and developing training programs to strengthen competency of relevant stakeholders, and strengthening local, regional, and international collaborations and coordination of NECs and NRAs for clinical trial oversight by developing joint clinical trial review guidelines.
Objectives
- To reinforce policy and legal framework for clinical trial oversight in Ethiopia, Tanzania and beyond
- To improve regulatory and research ethics oversight capacity and capability in Ethiopia, Tanzania and beyond
- To strengthen local, regional, and international collaborations and coordination of NECs and NRAs for clinical trial oversight in Ethiopia, Tanzania and beyond
Background
Better regulations of medicines development will ensure safety, efficacy, quality as well as availability of medicines and vaccines. Africa contributes to 15% of the global population and 70% of global disease burden. There is an increasing number of clinical trials being conducted in sub-Saharan Africa (SSA); however, the capacity of the regulatory and ethics committees for clinical trial oversight is limited due to poor infrastructure, shortage of skilled workforce, un-conducive working frameworks and lack of systems adequately supported by technology. Collaboration between academia, international organizations, National ethics committees (NECs) and national regulatory authorities (NRAs) are mandatory to produce sustainable regulatory skills and functional clinical trial oversight systems.
