ABSTRACT

JUDITH D. GOLDBERG and KENNETH J. KOURY Lederle Laboratories, American Cyanamid Company, Pearl River, New York

A multicenter clinical trial is a trial conducted at more than one distinct site. Such a trial provides replication and generalizability of results to a variety of patients and treatment settings. The design and analysis of such a trial involve ideas and methods that are fundamental to statistical thinking and scientific inference. In the application of a new treatment and the study of its effects, it is desirable to replicate the setting as well as the individuals tested within a specific setting. Therefore, the multicenter trial with site or center as a blocking variable provides a useful approach.