Data Monitoring Committees — Expect the Unexpected

• Published in: The New England journal of medicine Vol. 375; no. 14; pp. 1365 - 1371
• Main Authors: DeMets, David L, Ellenberg, Susan S
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 06.10.2016
• Series: The Changing Face of Clinical Trials
• Subjects: Clinical trials; Clinical Trials as Topic - standards; Clinical Trials Data Monitoring Committees; Data analysis; Multicenter Studies as Topic - standards; National Institutes of Health (U.S.); Patient safety; Patients; Research methodology; United States
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMra1510066

Randomized clinical trials require a mechanism to safeguard the enrolled patients from harm that could result from participation. This article reviews the role of data monitoring committees in the performance of randomized clinical trials. In the five decades since the completion of the Greenberg Report recommendations in 1967 (which were later published 1 ), independent groups of experts have monitored the progress of many clinical trials for early definitive evidence of benefit, convincing evidence of harm, or sufficient evidence of no potential benefit to render continuation of the trial to be futile. Such monitoring is motivated primarily by an ethical imperative; for trials of treatments intended to prevent or delay serious outcomes, one would want to stop the trial and make the superior treatment available as soon as the evidence was definitive. The assessment of . . .