CLINICAL DEVELOPMENT OF ATYPICAL ANTIPSYCHOTICS - RESEARCH DESIGN ANDEVALUATION

Clinical trials support the efficacy and safety of new drugs on the ma rket. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug applica tion and are the basis for package inserts provided by the manufacture rs that guide clinicians in the use of a new drug. Because clinical tr ials are vital to the effective and safe use of new drugs, it is impor tant to understand who participates in them, what questions are answer ed by clinical trials, and what questions are raised. The reader who a sks the proper questions about issues such as methodology, affiliation s of the investigators, statistical analyses performed, location of st udy centers, and study populations will derive the most information fr om the report of a clinical trial.