University of Pittsburgh Cancer Institute (UPCI)

Data Safety Monitoring Committee

Overview

The UPCI Data Safety and Monitoring Committee (DSMC) provides monthly oversight of study progress and safety by reviewing monthly meeting minutes, rates of accrual, accrual retention, frequency and severity of adverse events, and, where appropriate, the response rates in designated protocols. Interim DSMC meetings are scheduled to address specific issues that require immediate attention to ensure subject safety. The DSMC also assesses relevant new information, such as published scientific reports, or other developments that may affect subject safety or ethical concerns. The DSMC review is done to determine if there are changes to the anticipated risk/benefit ratio of a study that would affect its continuation.

UPCI and UPMC CancerCenter clinical trials are to be discussed at regularly scheduled disease site meetings involving the PI, co-investigators, and the clinical research coordinator. These discussions include each subject's treatment as described in the protocol and any significant toxicities that occur. The summary of these meetings is forwarded to the UPCI DSMC following a designated format. (See the Forms page for templates.) The DSMC has the authority to suspend accrual or further investigative treatments to any trial based on information received that warrants this action.

Based on information received that warrants action, the DSMC has the authority to suspend accrual or further administration of investigative treatments in any clinical trial being conducted at the UPCI and UPMC CancerCenter.