The Weill Cornell Medical College DSMB is available to aid WCMC principal investigators and the IRB in providing an independent means of data and safety monitoring for clinical trials that involve significant risk to research subjects. The WCMC DSMB reviews interim data on a schedule commensurate with the needs of a given protocol to evaluate research subject safety, rates of accrual, and efficacy of experimental intervention. After each evaluation, the Board provides the PI with recommendations for protocol modification, continuation or termination.
Studies for which the WCMC DSMB is appropriate as an independent method of monitoring include:
- Large, multi-site, randomized, blinded, and Phase III trials
- Phase I and II studies for which risk to the subjects appears unusually high
- Phase I and II studies for which the PI is the IND/IDE sponsor or manufacturer and independent monitoring is required to maintain the integrity of the trial
- Gene transfer studies
- Studies with vulnerable populations or risky interventions/procedures or any other factors that might indicate high morbidity/mortality end-points
- Studies with high risk of toxicity or other major medical risks