ABSTRACT
In this chapter we will provide a brief overview of the basic methods and operation of a data monitoring committee (DMC), relying on the many excellent publications that contain the standard, proven elements of the set-up and conduct of the DMC (Calis, et al, 2017; Herson, 2016; Ellenberg, Fleming, and DeMets, 2002). This overview will set the stage for several advanced topics, including the application of meta-analysis in safety assessment, Bayesian monitoring and simulations for positioning of both safety and efficacy results.
