Cancer-related investigator-initiated trials with an intervention involving a drug, device, or biologic are subject to review by the Data and Safety Monitoring Committee (DSMC).

DSMC reviews study information depending on type of trial (as outlined below) and may recommend continuation, suspension, or closure of a study.

DSMC Annual Renewal Form is required for all studies undergoing review by the DSMC.

Study Information Reviewed by the DSMC

Investigator-Initiated Trials Subject to Review That Do Not Have DSMB

  • Number of subjects
  • Unanticipated problems
  • List of Stopping Rules met – if applicable
  • List of Dose Limiting Toxicities and responses that have occurred in the specified time frame
  • Premature terminations of investigational treatment and other safety issues
  • Cumulative table of adverse events by type and grade, including deaths as outlined in the protocol-specific DSMP
  • Compliance data from monitoring, auditing, and noncompliance reports

Investigator-Initiated Trials Subject to Review That Have a DSMB

  • Number of subjects
  • Unanticipated problems
  • DSMB minutes and reports for accrual, stopping rules, adherence to protocol DSMP, and DSMB recommendations
  • Cumulative table of adverse events by type and grade, including deaths as outlined in the protocol-specific DSMP

DSMC Membership

Stephen Smith, MD

Chair, DSMC

Hematologic Malignancies

Heather Cheng, MD, PhD

Genitourinary Malignancies

Samantha Culwell, PharmD

Pharmacy

Chad He, PhD

Biostatistics, Public Health Sciences

Natasha Hunter, MD

Breast Oncology

Elizabeth Krakow, MD, CM, MS

Hematologic Malignancies, Immunotherapy

John Liao, MD, PhD

Gynecologic Oncology, Public Health Sciences

Christina Poh, MD

Hematologic Malignancies

Rachael Safyan, MD

Gastrointestinal Oncology

Katherine Tarlock, MD

Hematologic Malignancies, Pediatric Oncology

Diane Tseng, MD, PhD

Lung, Head and Neck Malignancies

Masumi Ueda, MD, MA

Hematologic Malignancies, Transplantation

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