Basic Principles of Setting Up Multicenter Trials

Abstract

Multicenter trials have the advantage of expanding the number of subjects available for study. With the added data potential come important drawbacks, including a greater chance for variability in data collection and protocol compliance and substantial fi nancial requirements. Conducting a multicenter clinical trial is a complex and time- consuming undertaking. A successful trial requires careful preparation, addressing par ticular attention to writing a comprehensive protocol, identifying responsibilities of key personnel, and adhering to a timetable. It is critical that all participating centers are adequately staffed by trained personnel, and that the principal investigator at each center is committed to collecting data in a uniform and blinded fashion. The purpose of the report is to review some general principles for setting up multicenter trials, fol lowed by a review of the recently completed study of the new antispasticity agent ti zanidine (conducted by Sandoz/Athena) to illustrate some of the pi...