PMID: 8440093Feb 1, 1993Paper

Operational and policy considerations of data monitoring in clinical trials: the Diabetes Control and Complications Trial experience

Controlled Clinical Trials
C Siebert, C M Clark

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 st...Continue Reading

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Citations

Apr 1, 1995·Controlled Clinical Trials·B A BlumensteinH E Mitchell
Sep 30, 1993·The New England Journal of Medicine·UNKNOWN Diabetes Control and Complications Trial Research GroupC Siebert
Jan 1, 1995·Annual Review of Medicine·O B Crofford
Oct 30, 1995·Statistics in Medicine·J C HornbergerJ Halpern
Jun 9, 2017·The Cochrane Database of Systematic Reviews·Marinella RuospoGiovanni Fm Strippoli
Nov 11, 2005·Clinical Trials : Journal of the Society for Clinical Trials·Felicity ClemensUNKNOWN DAMOCLES Group
Sep 25, 2018·The Cochrane Database of Systematic Reviews·Clement LoSophia Zoungas
Nov 12, 2005·Clinical Trials : Journal of the Society for Clinical Trials·Matthew R SydesUNKNOWN DAMOCLES Group

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