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J Clin Psychiatry. 2001;62 Suppl 9:17-20; discussion 21-2.

Clinical trial design issues in schizophrenic research.

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  • 1Mental Illness Research, Education & Clinical Center, Veterans Administration Medical Center, and the Oregon Health Sciences University, Portland 97201, USA.


Research studies are an indispensable tool in the Food and Drug Administration approval process. Becoming familiar with different research study designs helps one to understand and interpret the results of clinical trials. Research studies are undertaken with 2 major goals in mind: (1) to get a drug into registration (regulatory needs) and (2) to understand the clinical application of medicines (clinical application needs). This article discusses the 2 major goals of research studies, the design issues associated with those goals, and the design features of several recent comparative studies of atypical antipsychotics.

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