Clinical Trials Oversight and Management

In line with WANETAM’s vision to attain expertise to conduct clinical trials, research, and control of poverty-related diseases in West African institutions, the Clinical Trials Unit (CTU) of MRC The Gambia (MRCG) leads capacity strengthening efforts and provides a variety of support services to West African institutions focusing on capacity development, trial management and monitoring, holistic data management and statistical services.

As part of these capacity strengthening efforts, the training of Clinical Trials Associates (CRAs) also known as clinical trials monitors is designed to equip participants with the practical skills and knowledge to monitor and support vaccine, drug, and nutritional trials, with a focus on trials ongoing in resource constrained settings. To date, 23 CRAs have been trained.

With support from the CTU at the MRCG, the network supports its member institutions to implement Good Clinical Practice (GCP)-compliant trials by providing services such as risk assessments, site evaluation and selection, quality trial management, independent clinical trial monitoring (onsite and remote) and trial troubleshooting, to solve challenges such as low recruitment rates and high dropout rates. These are coupled with the possibility to link trials to other key departments at the MRCG such as the data management and statistics departments which will support quality data management processes and provide support for protocol design and sample size calculations, development of study database, data management plan, statistical analysis, perform study data analysis and the production of clinical study reports, among others.

Drawing inspiration from the lessons learnt from various previous trials, the CTU provides fitting solutions to trials related challenges by developing toolkits with templates and procedures to support the development of study plans and essential study documents, promoting the use of electronic adverse event reporting systems to improve pharmacovigilance in trials and enhancing trial management systems to facilitate real-time and risk-based oversight on trials progress.