Guideline Data Monitoring Committees

Clinical trials frequently extend over a long period of time. For ethical reasons it is desirable to ensure that for patients participating in such trials there is no unavoidable increased risk for harm. But it is also important to ensure that a trial continues for an adequate period of time and is not stopped too early to answer its scientific questions. An independent Data Monitoring Committee (DMC), as a group of experts external to a study that reviews accumulating data from an ongoing clinical trial, might serve such tasks for certain studies. While in general safety monitoring should be the major task for a DMC, other aspects of a clinical trial (e.g. study integrity, design aspects) might also be assessed by a DMC. However, it should be noted that a DMC is not needed for all clinical trials.