Abstract

Monitoring randomized clinical trials in Africa; pragmatic approaches and experiences from HIV trials

Author(s): Margaret J Thomason, Moira J Spyer1, Nicola Joffe1, Justine Boles, Andy Burke, Helen C Wilkes & Mary Rauchenberger

The Medical Research Council Clinical Trials Unit has coordinated HIV clinical trials in Africa for almost 15 years. Approaches to monitoring trial data have been developed using a combination of on-site and central (database) monitoring. Tools and templates have been designed to supplement trial protocols and help standardize trial processes. Local monitors supplement infrequent visits from the sponsor, enabling monitoring at the required intensity and allowing for capacity building. Database strategies have evolved to complement on-site visits, allowing more effective monitoring of data quality, and providing functionality in a cost-effective manner. Ongoing training and support of monitors and site staff is given via teleconferences, emails and meetings. Mentoring of site staff by monitors is encouraged, including cross-site visits where resources allow.