An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics.


Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Khan, A; Khan, SR; Leventhal, RM; Krishnan, KRR; Gorman, JM

Published Date

  • July 1, 2002

Published In

Volume / Issue

  • 52 / 1

Start / End Page

  • 62 - 67

PubMed ID

  • 12079731

Pubmed Central ID

  • 12079731

International Standard Serial Number (ISSN)

  • 0006-3223

Digital Object Identifier (DOI)

  • 10.1016/s0006-3223(02)01322-7


  • eng

Conference Location

  • United States