[DSMB. 2. The importance of an efficient DSMB: some examples of high-risk clinical trials]

Abstract

The DSMB (data safety and monitoring board) takes an increasing role in the monitoring of clinical trials, especially in large multicenter trials conducted in populations at high risk of morbidity or mortality. 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. A few examples, derived for recent experience of clinical trials conducted in acutely ill patients, illustrate the importance of an efficient and reactive DSMB to monitor patients' safety, especially during large multicenter trials.