Organization of multicenter clinical trials.

The typical multicenter trial involves several clinical centers, a data center, and other specialty centers as well. A common structure for large-scale trials funded by the National Institutes of Health (NIH) involves two or three key committees. One of these is comprised exclusively of investigators from the study (steering committee) and is responsible for operation of the trial. A second committee, usually comprised of individuals not involved in the study, is responsible for overseeing the trial and providing advice to the NIH regarding the study. A third committee--sometimes part of the second committee and comprised largely of individuals not involved in the trial--is responsible for monitoring the study results for evidence of adverse or beneficial treatment effects as the trial proceeds. The organizational design of a trial may be as important as the experimental design is in the success of the trial. Attention to organizational questions at the start of the study and periodic review and revision of the structure as the trial proceeds can help identify problems before they become major impediments to progress in the trial. Such ongoing monitoring and periodic review is especially important in the long-term multicenter trial.