Collaborative Staffing Model for Multiple Sites: Reducing the challenges of study coordination in complex, multi-site clinical trials.

The implementation of complex, multi-site clinical trials presents challenges that make recruitment efforts, participant follow-up, and organization of staff critical to the success of the overall outcome. This article describes a unique staffing model utilized by the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study, an NIH (National Institutes of Health) sponsored trial designed to explore treatment options for type 2 diabetes in youth. At each study center, the program coordinator (PC) and diabetes educator (DE) work together to implement the study protocol. A staffing model that provides this type of mutual support for two key members of the study team may decrease the burden customarily encountered solely by the PC in complex trials, and furthermore allows for cross-coverage and flexibility. To determine the degree of overlap and task sharing between the PC and DE across study sites, a self-administered survey was distributed to all PCs and DEs. Survey results as well as specific examples demonstrating an effective collaborative approach by front-line study personnel in managing various challenges encountered in study implementation are included.