Presented by Distinguished VCU Biostatistics Alumnus
Frank W. Rockhold, Ph.D.
Professor of Biostatistics & Bioinformatics
Duke University Medical Center and Duke Clinical Research Institute
Affiliate Professor
Virginia Commonwealth University
Over the past seven decades, the randomized clinical trial (RCT) has evolved to serve as the benchmark for the evaluation of new pharmaceuticals, medical devices, procedures, and behavioral interventions. Correspondingly, the role of the Independent Data Monitoring Committee (IDMC), also known as the Data and Safety Monitoring Board (DSMB), which was first recommended by the Greenberg Report in 1967, has similarly advanced. IDMCs are responsible for reviewing the complete body of evidence—including emerging unblinded data—and may recommend modifications to the RCT or early termination when there is evidence of harm or compelling benefit. The utilization of independent Data Monitoring Committees and Data and Safety Monitoring Boards in clinical trials continues to rise. Alongside this increased adoption over the last five to six decades, there has been a significant expansion in the use of independent statistical reporting groups (ISRGs), which supply interim reports for IDMC review. Despite substantial growth, there remains a notable shortage of clinical and statistical scientists with the necessary training and expertise to serve as members of IDMCs or provide ISRG-type support. This presentation will outline fundamental aspects of DMC operations, including typical responsibilities, committee composition, meeting structure, operational policies, and current issues—both emerging and controversial—in data monitoring. The objective of this discussion is to enhance understanding of DMC operations and address the ongoing challenges within the clinical trials community.