ABSTRACT
This chapter provides a brief overview of the basic methods and operation of a data monitoring committee (DMC), and focuses on the many excellent publications that contain the standard, proven elements of the set-up and conduct of the DMC. Data monitoring committees thus have a valuable contribution to make in the drug development process, and their purview covers many concepts of safety, efficacy and therefore clinical benefit. DMC has a number of functions and activities, which include administrative work, safety data monitoring, and interim analysis for efficacy and to determine whether the trial can demonstrate a reasonable risk-benefit ratio. The DMC biostatistician must be knowledgeable about statistical methods for clinical trials and sequential analysis of trial data, preferably with experience in the therapeutic area under study, but also with a varied background in general methods used in all phases of clinical trials of all sample sizes.
