Eleni Aklillu

Why RER-CTO?: 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. The capacity of most African regulatory authorities regarding clinical trial review and oversight is weak due to poor infrastructure, limited resources both human and financial, lack of expertise, un-conducive working framework 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. 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. These efforts are geared towards increasing clinical trials in sub-Saharan Africa, standardization of clinical trial review and monitoring processes, and promoting ownership, efficiency, linkages for data sharing, transparency, and accountability of clinical trial review processes.

Africa’s regulatory authorities lack the resources and infrastructure to oversee clinical trials effectively. To address these challenges and improve oversight systems, collaboration between academia, international organisations, national ethics committees, and regulatory authorities is essential. The EU-funded RER-CTO project aims to enhance ethical and regulatory standards for trial oversight (CTO) in sub-Saharan Africa. It focuses on identifying gaps in the legal and policy framework, improving regulatory and research ethics oversight capacity through the digitalisation of CTO systems, developing training programmes, and fostering collaboration among NECs and NRAs to create joint clinical trial review guidelines. The project involves clinical trial researchers, regulatory authorities, ethics committees, universities, and research institutes from Ethiopia, Tanzania, Norway, and Sweden.