Data and Safety Monitoring Board

Data and safety monitoring boards (DSMBs), sometimes referred to as data monitoring committees, are groups of experts in relevant disciplines, typically medicine and biostatistics, charged with examination of interim data in an ongoing prospective study, often a randomized clinical trial. DSMBs monitor accumulated safety data such as reported adverse events to determine whether study continuation is reasonable based on acceptable risk versus benefit to participants. DSMBs may also review interim data on efficacy outcomes, with the possibility of recommending early trial stopping under strong evidence of treatment efficacy and/or futility if the study were continued. This entry describes the composition and operations of a DSMB and provides examples of monitoring activities.