Larkin Mary E, McGuigan Paul, Richards Denise, Blumenthal Karen, Milaszewski Kerry, Higgins Laurie, Schanuel Jill, Long Christen
TODAY Study Diabetes Educator Committee.
Rainbow Babies and Children's Hospital CASE Medical Center.
Appl Clin Trials. 2011 Jan 1;20(1):30-35.
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.
开展复杂的多中心临床试验面临诸多挑战，这使得招募工作、受试者随访以及工作人员的组织安排对于整体试验结果的成功至关重要。本文介绍了由“青少年及青年2型糖尿病治疗选择（TODAY）”研究采用的一种独特人员配置模式，该研究是一项由美国国立卫生研究院（NIH）资助的试验，旨在探索青少年2型糖尿病的治疗方案。在每个研究中心，项目协调员（PC）和糖尿病教育者（DE）共同努力实施研究方案。为研究团队的两名关键成员提供这种相互支持的人员配置模式，可能会减轻在复杂试验中通常仅由项目协调员承担的负担，而且还能实现交叉覆盖和灵活性。为了确定各研究地点的项目协调员和糖尿病教育者之间的重叠程度和任务分担情况，我们向所有项目协调员和糖尿病教育者发放了一份自行填写的调查问卷。文中包括了调查结果以及一线研究人员在应对研究实施过程中遇到的各种挑战时采取有效协作方法的具体实例。
