Contact Us
News

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).

The DSMC reviews study information depending on type of trial (as outlined below) and may recommend a Full Approval, a Conditional Approval, or a Suspension.

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

Key Contacts

DSM@fredhutch.org for assistance with data and safety monitoring functions

Study Information Reviewed by the DSMC

Investigator-Initiated Trials without a 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 with 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

Fred Hutch IDS Pharmacy

Lei Deng, MD

Lung, Head and Neck, Thoracic Oncology

Evan Hall, MD, MPhil

Renal & Melanoma Oncology

Chad He, PhD

Biostatistics, Public Health Sciences

Natasha B. Hunter, MD

Breast Oncology

John Liao, MD, PhD

Gynecologic Oncology, Public Health Sciences

Shivaprasad (Shiva) Manjappa, MBBS, MPH

Hematologic Malignancies

Vidhya Nair, DO

Breast and Ovary Cancers

Christina Poh, MD

Hematologic Malignancies

Daniel Runco, MD

Pediatric Oncology; Neuro-Oncology

Rachael Safyan, MD

Gastrointestinal Oncology

Lynn Symonds, MD

Breast cancer

Katherine Tarlock, MD

Hematologic Malignancies, Pediatric Oncology

Masumi Ueda, MD, MA

Hematologic Malignancies, Transplantation