Data monitoring committee (DMC)
What is a data monitoring committee (DMC)?
A data monitoring committee (DMC) is a group of biostatisticians and clinicians appointed by study sponsors to provide an independent assessment of the safety, integrity, and validity of a clinical trial. The FDA requires that all trials assessing new interventions have a DMC, but they are also strongly recommended for any clinical study with substantial safety issues, such as those expected to have a major impact on clinical practice and those with double-blind treatment assignments.
The findings of the DMC are used to decide whether a trial should continue as it was designed, if it needs to be changed to improve participant safety and collect more accurate data, or if the clinical trial should be terminated.
Why are DMCs important for healthcare?
DMCs offer extra protection for the vulnerable populations volunteering to participate in clinical trials. As an entity independent of the study sponsor, the DMC can make objective recommendations to the sponsors without bias.
In addition to monitoring the safety of a clinical trial, the DMC must also assess the ongoing scientific merit and validity of the clinical trial to monitor participant recruitment, protocol compliance, and the quality of data collected.