Guidance on Data Monitoring Committees

Clinical trials frequently extend over a long period of time. Thus, for ethical reasons it is desirable to ensure that for patients participating in such trials there is no unavoidable increased risk for harm. On the other hand 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. 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.

When monitoring a clinical trial a DMC might have to review accumulating data from an ongoing clinical trial in an unblinded fashion. Based on these reviews, a DMC has the capacity to make recommendations that might impact the future conduct of the trial. As access to unblinded treatment information during a clinical trial has the potential to introduce bias to future trial results, there are several aspects that require detailed regulatory consideration in order to ensure the scientific integrity of a clinical trial involving a DMC.

All investigators setting up a clinical trial sponsored by NUH should read the EMEA guidance and consult with their research Manager. A DMC Charter is also available.