[DSMB. 1. What role, what responsibilities?].
In addition to the IRB (Institutional review board), the DSMB (data safety and monitoring board) takes an increasing role in the monitoring of clinical trials, especially in large multicenter trials. The DSMB is a an expert committee, independent from the investigators and the sponsor of the trial, which periodically examines the safety data accumulated during progress of the trial and ensures that the benefit/risk ratio remains acceptable for participating patients. The DSMB is also a safeguard for the scientific integrity of the trial. It is the only committee which can have access to unblinded data from the trial. The DSMB may recommend termination of the trial in three situations : (1) occurrence of unanticipated adverse events which may pose a serious risk for participating patients; (2) demonstration of efficacy before the planned accrual \; (3) and because of "futility" (the most difficult situation), i.e. in absence of a reasonable probability that the trial may reach a conclusion within its planned frame.
Brun-Buisson
Christian
C
Service de Réanimation médicale, CHU Henri Mondor, 51, avenue du Maréchal de Lattre de Tassigny, 94010 Créteil Cedex, France. christian.brun-buisson@hmn.ap-hop-paris.fr
D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration / Q000592:standards