All clinical studies conducted at Sylvester must include provisions for data and safety monitoring. The DSMC conducts data and patient safety reviews on cancer related institutional, interventional studies that entail risk(s) to participants. Protocols that are externally peer reviewed by the NIH, NCTN and the NCI, CTEP do not require additional data and safety monitoring at the institutional level.
The Sylvester DSMC evaluates all new investigator-initiated studies to ensure patient safety monitoring is commensurate with risk.
The DSMC is responsible for:
- Protecting participant safety
- Ensuring the credibility and integrity of the data
- Providing analysis of efficacy data and interim reviews of safety monitoring
The DSMC is composed of experts in relevant scientific disciplines to ensure critical data and safety review of all cancer related institutional, interventional studies. The committee comprises medical oncologists, scientists, nurses, clinical research coordinators, regulatory analysts a statistician, and a pharmacist.
Marilyn Huang, M.D.