title: Operational and policy considerations of data monitoring in clinical trials: the Diabetes Control and Complications Trial experience.
abstract: Many clinical trials incorporate a system for monitoring emerging data that utilizes a committee composed of individuals who are independent of the investigators conducting the study. Although this is a common practice, there is a paucity of publications examining the operating methods of these groups. This paper describes the composition, functions, and procedures of the Data, Safety and Quality Review Group (DSQ) of the Diabetes Control and Complications Trial (DCCT). The DSQ is not masked to emerging data and the voting membership is made up of individuals with a wide diversity of expertise that reflects the needs of the trial. There are also nonvoting exofficio members who represent other components of the study organization. In addition to data monitoring, the DSQ provides external review of coordinating center operations. A distinctive aspect of the DCCT's DSQ is the creation of a free-standing operations manual for the DSQ's use during the trial and the involvement of the study investigators in developing certain sections of this document. Utilizing a process that allowed participation of the investigators was considered critical to achieving a mutual understanding regarding the planned uses and interpretations of the study data prior to the study's completion so as to minimize the chances of major disagreements regarding the conclusions drawn. Equally important, the existence of such a manual provides documentable reassurance to all interested parties that both scientific integrity and patient safety are being closely watched and gives the study investigators confidence that the results of the study will be scientifically credible and clinically important.
authors.affiliation: NIDDK, NIH, Bethesda, Maryland 20892.
authors.forename: C
authors.initials: C
authors.lastname: Siebert
authors.forename: C M
authors.initials: CM
authors.lastname: Clark
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000517:prevention & control*; D003929:Diabetic Neuropathies / Q000517:prevention & control*; D016903:Drug Monitoring / Q000706:statistics & numerical data*; D006801:Humans; D011785:Quality Assurance, Health Care; D016896:Treatment Outcome