title: Hypothesis and hypothesis testing in the clinical trial.
abstract: The hypothesis provides the justification for the clinical trial. It is antecedent to the trial and establishes the trial's direction. Hypothesis testing is the most widely employed method of determining whether the outcome of clinical trials is positive or negative. Too often, however, neither the hypothesis nor the statistical information necessary to evaluate outcomes, such as p values and alpha levels, is stated explicitly in reports of clinical trials. This article examines 5 recent studies comparing atypical antipsychotics with special attention to how they approach the hypothesis and hypothesis testing. Alternative approaches are also discussed.
authors.affiliation: Department of Psychiatry and Mental Health and Neuroscience Clinical Research Center, University of North Carolina School of Medicine, Chapel Hill 27599-7160, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Lieberman
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D003987:Dibenzothiazepines / Q000627:therapeutic use; D006801:Humans; D000077152:Olanzapine; D010506:Periodicals as Topic / Q000592:standards; D010890:Pirenzepine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011618:Psychotic Disorders / Q000188:drug therapy; D011643:Publishing / Q000592:standards; D000069348:Quetiapine Fumarate; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D018967:Risperidone / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D009626:Terminology as Topic
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D001569:Benzodiazepines; D000069348:Quetiapine Fumarate; D010890:Pirenzepine; D018967:Risperidone; D000077152:Olanzapine