DATA AND SAFETY MONITORING COMMITTEE

The members of the Data and Safety Monitoring Committee (DSMC) function independently of study leadership, are governed by formally documented policies and procedures, and are free of conflicts of interest. The committee is responsible for:

  • Ensuring the safety of study participants
  • Reviewing findings from interim analyses of outcome data and summary reports of adverse events
  • Reviewing major modifications proposed by the trial team
  • Reviewing trial performance in accrual and data collection
  • Advising on data releases prior to the reporting of study results
  • Reviewing additional data that may become available
  • Ensuring that study investigators remain free of the bias associated with knowledge of interim study results

The DSMC monitors all active Network protocols, with the exception of large screening trials that warrant dedicated oversight committees. In meetings held at least twice a year, the DSMC receives a summary report of the status of all trials with regard to accrual and data collection, adverse events/toxicity, and outcome data. Following a three-session review of each trial in which outcome results are discussed only by DSMC members and a statistician, the DSMC recommends to the Network Chair to change the study, continue the study, or stop the study.

Committee Members

Ruth Carlos, MD, MS, Chair
Joseph Aisner, MD
Al Benson, MD
Laura J. Hilderley, RN, MS
Nora Jaskowiak, MD
Ritsuko Komaki, MD, FACR
Jon F. Merz, MBA, JD, PhD
Sheila G. Moore, MD
Nancy Obunchowski, PhD
Clare Tempany, MD

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