ABSTRACT
A data monitoring committee (DMC) is a group of individuals charged with monitoring the accumulating data of an ongoing clinical trial and taking actions based on their findings. The DMC’s primary responsibility is typically to protect the safety of the trial participants by periodically reviewing the safety data, and, if they discover any unacceptable safety risks, recommending modifications to the study to alleviate that risk or termination of the study. The DMC can also go by a number of different names, such as data and safety monitoring board (DSMB) or ethical review committee (ERC), but the responsibilities are the same regardless of the name. DMCs have become relatively routine for many clinical trials, and there is a large literature on the topic, including several overview articles (e.g., Ellenberg 2001; Wilhelmsen 2002), two text books (Ellenberg, Fleming, and DeMets 2002; Herson 2009), and one book of case studies (DeMets, Furberg, and Friedman 2006). Pocock (2006) discussed some real-life challenges that can face a DMC. While many issues associated with DMCs apply equally to adaptive and nonadaptive trials, certain features of adaptive trials raise special issues with regard to the composition and functioning of a DMC.
