title: Pharmacoepidemiology 101: data monitoring committees in the post-marketing approval setting.
abstract: The development of the risk management paradigm for the enhancement of post-marketing approval drug safety carries with it the need for external monitoring of the different approaches used by the sponsor. The concept of a Data Monitoring Committee (DMC), widely used in the management of randomized clinical trials, is adapted to provide this monitoring function. The rationale for the post-marketing approval DMC is considered in the context of the risk management paradigm, as well as in the more traditional post-marketing approval surveillance setting. The composition and operation of the post-marketing approval DMC are considered, as well as the process of implementing the committee. Although the adaptation proposed in this article is focused on the paradigm proposed by the United States Food and Drug Administration, it is likely that it will require modification as risk management is adopted (and adapted) by other health regulators.
authors.affiliation: Department of Global Epidemiology and Outcomes Research, Pharmaceutical Research Institute, The Bristol-Myers Squibb Company, Princeton, NJ 08543-5400, USA. david.lilienfeld@bms.com
authors.forename: David E
authors.initials: DE
authors.lastname: Lilienfeld
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D004345:Drug Industry; D016903:Drug Monitoring; D006801:Humans; D017146:Models, Organizational; D017891:Pharmacoepidemiology / Q000379:methods*; D012308:Risk Management / Q000458:organization & administration*; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration