title: An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics.
abstract: BACKGROUND
  Recent years have seen the introduction of many antidepressants and antipsychotics. Typically, efficacy of these agents is based on published positive clinical trials; however, the Food and Drug Administration (FDA) compiles summary reports of all pivotal randomized clinical trials, which are available for public review under the Freedom of Information Act. They are rarely accessed but may have public health utility. Thus, we assessed these reports to evaluate if the clinical data can be used for comparing psychotropics.
  
  
  METHODS
  We examined FDA summary reports of 58 pivotal trials from 10 antidepressants and 7 pivotal trials from three antipsychotics approved in the United States between 1985 and 1998. We evaluated each FDA report based on criteria derived from the recently revised Consolidated Standards of Reporting Trials (CONSORT standards) proposed by the Journal of the American Medical Association to improve randomized clinical trial reports.
  
  
  RESULTS
  Overall, the FDA reports of antidepressant and antipsychotic trials adequately met 38.1% of the CONSORT criteria. Among the antidepressant reports, 36.7% adequately met CONSORT criteria compared with 49.0% among the antipsychotic reports. The proportions meeting CONSORT criteria have increased over the past 15 years; 21.0% for those approved between 1985 and 1989, 37.8% for those between 1990 and 1994, and 40.5% for those between 1995 and 1998.
  
  
  CONCLUSIONS
  The large and inclusive public domain FDA summary reports may provide balanced efficacy clinical trial data. With minor changes in the preparation of reporting by using CONSORT or similar guidelines, the data would be even more valuable.
authors.affiliation: Northwest Clinical Research Center, Bellevue, Washington 98004, USA.
authors.forename: Arif
authors.initials: A
authors.lastname: Khan
authors.forename: Shirin R
authors.initials: SR
authors.lastname: Khan
authors.forename: Robyn M
authors.initials: RM
authors.lastname: Leventhal
authors.forename: K Ranga R
authors.initials: KR
authors.lastname: Krishnan
authors.forename: Jack M
authors.initials: JM
authors.lastname: Gorman
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D017277:Drug Approval; D006801:Humans; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000928:Antidepressive Agents; D011619:Psychotropic Drugs