RER-CTO

The challenge

It is essential that clinical trials in sub-Saharan Africa are conducted safely and ethically. Responsibility for ensuring such conduct generally lies with national regulatory authorities and research ethics committees (national and institutional). Despite much progress over the past two decades (including multiple capacity-building projects supported by EDCTP programmes), the capacity to oversee clinical trials varies significantly between countries in sub-Saharan Africa.

Although the safe and ethical conduct of clinical trials is a top priority, it is also important that the review of clinical trial applications and the monitoring of ongoing studies are carried out expertly and efficiently to avoid unnecessary delays and to ensure that countries are favoured locations for conducting research. In multiple countries, there remains considerable scope to strengthen the capacity of individual members of research ethics committees and to enhance the efficiency of regulatory and ethics review systems, as well as their coordination.

The project

The RER-CTO project is strengthening capacity, improving efficiency and enhancing coordination across clinical trial oversight structures in Ethiopia and Tanzania, two countries at different levels of maturity but with a shared desire to attract more clinical trial activity.

The project is undertaking a range of activities, including:

• Mapping the legal and policy frameworks in the two countries, making comparisons with international standards, and supporting the development of updated legal and policy documents when necessary.
• Supporting the introduction of digital clinical trial application and monitoring systems in Ethiopia, which currently relies on manual submissions, and the enhancement of existing electronic systems in Tanzania.
• Mapping training needs in the two countries for research ethics committee members and national regulatory authority staff, followed by the development of short courses in clinical trial monitoring and research ethics; one to three courses will be delivered to around 100 individuals.
• Developing joint clinical trial review guidelines for national regulatory authority and national ethics committees to ensure coordinated post-approval monitoring, drawing on guidance developed by the African Vaccine Regulatory Forum (AVAREF). 

In addition, the project is working to strengthen collaboration and mutual support across the two countries.

Impact

The RER-CTO project will help to significantly strengthen and harmonise regulatory and ethics review capacity in Ethiopia and Tanzania: It will:

• Facilitate the introduction and optimisation of new digital systems to accelerate regulatory and review processes.
• Support harmonised approaches across regulatory and ethics review bodies to improve the efficiency of clinical trial application assessment and monitoring.
• Build expertise in key issues in research ethics and clinical trial oversight in the two countries.
• Generate comprehensive training materials that will be made available to other countries.

Collectively, these activities will make both Ethiopia and Tanzania more attractive places in which to conduct clinical research, increasing clinical trial activity and accelerating the evaluation of new medical interventions.