The role of an independent data monitoring board in a clinical trial sponsored by a pharmaceutical firm

While the use of independent data monitoring boards (MDBs) has become common in long-term follow-up clinical trials sponsored by the National Institutes of Health, they have been rarely used in clinical trials sponsored by pharmaceutical firms. This paper describes the use of a DMB by a pharmaceutical firm to administer interim analysis and an early termination rule for a multicenter placebo-controlled double-blind clinical trial for stress-related upper gastrointestinal bleeding. The organization and operations of the DMB and its relationship to the trial sponsor are described. A clear charter of DMBs and sponsor responsibilities, careful planning and rehearsal of DMB activities, continuous communication with the sponsor, a DMB of no more than five members consisting of clinicians who are not investigators in the trial, and a biostatistician are recommended to increase the likelihood of success. Use of a DMB is found to be a viable means of protecting patients from unnecessary exposure to ineffective and/or unsafe drugs and of protecting sponsors from credibility issues concerning the trial's outcome.