SCALE-IT

The challenge

East African countries are hosting an increasing number of clinical trials, many of which are adopting innovative designs such as adaptive platform-based trials. At the same time, there are increasing pressures to increase the speed of review of clinical trial applications.

These trends are posing a growing challenge to national regulatory authorities and ethics review committees, including an increasing workload. It is critical that there is a sufficiently large pool of trained scientists in the region who can review clinical trial applications, including complex study designs. There is also a need to enhance oversight to ensure the safety of trial participants. 

The project

Uganda has hosted multiple EDCTP capacity-building projects. One such project helped to develop a national accreditation system for research ethics committees in Uganda, which was used to accredit all 29 such committees in the country. The EDCTP-funded CREDU project developed the capacity of Uganda’s national regulatory authority through ethics and regulatory training, mentorships and placements of staff in more mature regulatory bodies. 

However, there remains a need to strengthen trial monitoring further and to extend good practices to additional countries, guaranteeing international standards and attainment of  Sustainable Development Goal 3.As well as Uganda, the SCALE-IT project connects Burundi, Kenya, Rwanda, South Sudan and Tanzania. 

To achieve these goals, the SCALE-IT project is undertaking a range of activities, including:

• Training of regulatory authority staff, ethics review committee members, researchers and clinicians on scientific and ethics review, with a particular focus on adaptive platform-based trials. The project will make use of a training curriculum developed through a project funded by the US National Institutes of Health (NIH).
• Training of regulatory authority staff, ethics review committee members, and clinical trials monitors on oversight, monitoring and pharmacovigilance of clinical trials. To improve accessibility, training will be delivered through a more convenient blended learning approach.
• Training of regulatory authority staff, ethics review committee members and research administrators on personal effectiveness and leadership skills, again based on blended learning.

The East African Health Research Commission (EAHRC) is acting as the focal point of the project. The EAHRC was established by the heads of state of East African Community (EAC) countries, with the main objective to promote, facilitate and coordinate the conduct and application of health research in the EAC.

Impact

The SCALE-IT project will continue past work to strengthen regulatory and ethics review capacity in Uganda, and connect multiple countries in East Africa. It will:

• Improve the performance of regulatory and ethics review bodies, particularly their handling of trial applications for adaptive platform-based trials.
• Lead to more rapid assessment of clinical trial applications.
• Ensure high-quality feedback is provided to clinical trial applicants.
• Facilitate enhanced monitoring of approved clinical trials.

Collectively, the project activities will make the region a more attractive location for clinical trials to accelerate the development, delivery and uptake of new and improved safe health technologies and rapid response to emerging epidemics for people of all ages living in East African Community countries.