Data monitoring and safety committees and their operations.
The scientific burden of proof for new therapies and technologies in obstetrics and gynecology has risen steadily over the past 15 to 20 years, and the randomized clinical trial has become integral to this higher standard. Data monitoring and safety committees are now critical components of clinical trials, yet their history, rationale, methods of operation, and overall role have not been well-characterized in the obstetrics and gynecology literature. In this review, an overview of the important and evolving role of data monitoring and safety committees is provided.


BACKGROUND
Obstetricians & Gynecologists, Family Physicians.


OBJECTIVE
After completion of this article, the reader will be able to describe what a data monitoring and safety committee is, plan who should comprise the DMSC, and outline the functions of a DMSC.
Center for Research in Women's Health, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35249-7333, USA. drouse@uab.edu
Dwight J
DJ
Rouse
D026661:Clinical Trials Data Monitoring Committees; D006176:Gynecology / Q000639:trends; D006801:Humans; D009774:Obstetrics / Q000639:trends; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012449:Safety