Data Monitoring Committees — Expect the Unexpected
Cet article analyse les enjeux associés au rôle des comités de surveillance et de suivi dans l'évaluation des risques et bénéfices d'un essai clinique en cours
In the five decades since the completion of the Greenberg Report recommendations in 1967 (which were later published), 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 risk versus benefit throughout the course of the trial requires frequent access to accumulating data on efficacy and safety. To allow investigators and sponsors to manage the trial without bias, as well as to ensure an objective assessment of the accumulating data, independent committees, known as data monitoring committees (DMCs), data and safety monitoring boards, or other aliases, are established to perform this monitoring function and to make recommendations regarding trial modifications, including early termination, to investigators and sponsors. These committees require multidisciplinary expertise and experience, including knowledge of statistical methods for interim data monitoring; they also pay attention to recruitment progress and the general quality of the trial with respect to adherence to the protocol and completeness of data collection and follow-up...
New England Journal of Medicine , article en libre accès, 2015