THE IMPACT OF THE TRIAL COORDINATOR IN THE DIABETES CONTROL AND COMPLICATIONS TRIAL (DCCT)

The Diabetes Control and Complications Trial (DCCT) is a multicenter r andomized clinical trial studying the effects of two different diabete s regimens on the development and progression of early vascular compli cations in persons with insulin-dependent diabetes mellitus (IDDM). Al l of the centers have a Trial Coordinator We administered a self-repor t questionnaire to each center to document the different activities fo r which the Trial Coordinator assumed responsibility in successfully o rchestrating the trial. All Trial Coordinators were responsible primar ily for recruitment, screening, medical management, education and trai ning, and adherence and administration. Although documentation indicat ed that the Trial Coordinator was responsible for all of the above act ivities, the original applications reflected that very few of the Prin cipal Investigators anticipated such a wide variety of duties. A Trial Coordinator was named in only 13 of the 21 applications and of these, only 6 actually assumed the position. This study points out the need to develop a means to define characteristics, background, and training appropriate for candidates for a Trial Coordinator position in future studies.