The role of the data safety and monitoring committee in stroke trials.

There are many good reasons why any human experiment should have appropriate oversight. In clinical trials, the data safety and monitoring committee (DSMC) serves to protect the interests of the patients. In stroke trials, its members usually together represent a broad expertise in neurology, internal medicine, cardiology and biostatistics. Independency and integrity are key words, especially in the relationship to the sponsor of the trial. The DSMC members should have no long-term financial strings to the sponsor, and they should not be personally involved in patient recruitment and evaluation. The DSMC provides recommendations to the steering committee of the trial on whether to continue or to stop patient recruitment and on protocol amendments that may be necessary to protect the safety of the patients. Copyright 2003 S. Karger AG, Basel