Basic Principles of Setting Up Multicenter Trials

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...