Site engagement for multi-site clinical trials

Abstract

Multi-site clinical trials are essential within medical practice to help drive reliable and generalizable knowledge on advancing medical treatments. Although the success of multi-site trials is significantly dependent on local clinician and site research teams, best practices for engagement of site teams, or “site engagement,” has not been extensively discussed. Site engagement centers on including sites in the planning and implementation of clinical trials to promote trial enrollment, compliance, and applicability to local contexts. Using a case example from the RadComp Trial, a longitudinal, multi-site clinical trial, novel site engagement practices are provided across three major research phases. In the Planning Phase, site engagement builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. In the Conducting Phase, sustained engagement encourages bi-directional communication and facilitates learning networks for enhanced site performance. In the Dissemination Phase, site and community partnerships are leveraged to create locally designed dissemination plans for broader scientific reach and impact. Site engagement practices discussed in this paper can be replicated or molded for application in other multi-site clinical trials.

Keywords

• Research engagement
• Site engagement
• Multi-site clinical trials
• Comparative effectiveness research
• Clinical trial design