A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is an independent body of experts (e.g., clinicians, biostatisticians, ethicists) that regularly reviews data accruing during a clinical trial. The primary objective of the DMC is to ensure the safety of study participants and to maintain the scientific integrity of the study.
The DMC has access to unblinded data and can, on this basis, make recommendations to the sponsor, e.g., to continue, modify, or prematurely terminate the study due to safety concerns, overwhelming efficacy, or lack of prospect of success (futility). For CROs, organizing and coordinating DMC meetings is an important task that requires careful data preparation and strict adherence to confidentiality.