UPCI Data and Safety Monitoring Committee (DSMC)

The UPCI 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 Cancer Centers 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. (Form can be accessed below.) 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 Cancer Centers.

Specific DSMC Responsibilities:

  1. Review all internal related or unrelated SAE reports and unanticipated events from studies to assess if there is a change in the risk/benefit ratio that might affect study continuation.
  2. Submit recommendations for corrective actions to the Principal Investigator.
  3. Review minutes from data safety monitoring committees, external to the UPCI and UPMC Cancer Centers (i.e., Phase I, Phase II, Phase II, IV Prevention Trials, etc.). Also reviews scientific reports or other literature that may have an impact on subject safety or continuation of the trial.
  4. Review other matters that pertain to serious errors or potential misconduct by any of the trial investigators and their research staff such major protocol violations or breeches in subject or sponsor confidentiality.
  5. Review any other matters that present safety issues to subjects enrolled on clinical trials not addressed above.

Downloadable Forms:

For more information on the DSMC, contact: Brandon Kaukus, DSMC Coordinator, at kaukusbm@upmc.edu.