abstract:A Data Monitoring Committee (DMC) – sometimes called a Data and Safety Monitoring Board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
The North CentralCancerTreatmentGroupDataSafetyMonitoringCommitteeinterrupted enrollment at a planned interimanalysiswhenoutcomescrossed predeterminedstoppingboundaries.
The datamonitoringcommittee overseeing the trial said patients were unlikely to benefit from the treatment, and identified higher adverse events in the subjects receiving the drug compares to placebo.