Clinical trial design issues in schizophrenic research.
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.
Casey
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Mental Illness Research, Education & Clinical Center, Veterans Administration Medical Center, and the Oregon Health Sciences University, Portland 97201, USA.
D014150:Antipsychotic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D017277:Drug Approval / Q000379:methods; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D012559:Schizophrenia / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
D014150:Antipsychotic Agents