When investigating a new drug, device, or procedure, clinical trials encounter risks to participant safety and well-being and data validity and integrity. A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is a powerful mechanism to manage these risks.
A multidisciplinary group set up by the study sponsor,
Comprised of individuals with expertise in the specific indication of a clinical trial,
Charged with regular review of clinical study data to monitor a clinical study’s safety and/or efficacy parameters.
A DMC should be independent of the sponsor and the clinical trial’s conduct. DMCs play a unique role in ensuring the safety of human subjects enrolled in clinical studies. During the past 30 years, the use of DMCs increased significantly – from 10% of trials reported in high-impact journals in 1990 to 25% in 2000 and 35% of industry-sponsored clinical trials in 2007-20101,2. The use and role of DMCs have also evolved, and their management has become more challenging and complicated. Among these challenges, four are particularly important for the DMC’s functioning and, in turn, the whole investigational program.
A DMC is a crucial independent group comprised of experts in a specific indication of a clinical trial, responsible for regularly reviewing study data to ensure the safety and efficacy of human subjects enrolled in clinical studies.
