A pragmatic and innovative strategy to improve quality of clinical trials in Eastern Africa: Update from the Reciprocal Monitoring Scheme (RMS)
Contract Research Organizations (CROs) are conventionally used to monitor quality of clinical trials. They are expensive for resource-constrained settings yet associated with limited capacity-strengthening to be sustainable. In April 2010, the EDCTP funded East African Consortium for Clinical Research (EACCR) in partnership with the University of Oxford initiated a reciprocal monitoring scheme (RMS) with in-built mentoring.
METHODS:
Between September 2011 and April 2013, two RMS co-coordinators built on best practices and experiences in clinical monitoring from a clinical trial facility in Kilifi, Kenya liaised with heads of research institutions, principal investigators and nominated potential monitors to conduct cross-site monitoring of each prioritized trial for 3 days in Eastern Africa. These coordinators from Kenya and Uganda facilitate operational oversight, logistical support and mentoring of nominated monitors. An experienced monitor is paired to a new or less experienced one to generate an expanding pool. Assigned pairs conduct introductory and subsequent monitoring visits for ongoing trials that they are not associated with.
RESULTS:
We conducted three skill-sharing workshops for 28 members, including seven new ones. Twenty five members, including two new ones, monitored 16 clinical trials through 32 completed paired visits. We recently welcomed two new monitors from Rwanda. We have attracted and completed two consultancy requests from regional research sites.
CONCLUSIONS:
This is a pragmatic platform for monitoring quality and regulatory processes of clinical trials in resource-constrained settings. After evaluation of cost effectiveness, this model could be considered as a replacement for internationally contracted monitors for clinical trials.