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Research Article

Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis

  • Kirby Lee,

    Affiliation: Department of Clinical Pharmacy, University of California San Francisco, San Francisco, California, United States of America

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  • Peter Bacchetti,

    Affiliation: Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, United States of America

    X
  • Ida Sim mail

    To whom correspondence should be addressed. E-mail: ida.sim@ucsf.edu

    Affiliation: Division of General Internal Medicine, University of California San Francisco, San Francisco, California, United States of America

    X
  • Published: September 23, 2008
  • DOI: 10.1371/journal.pmed.0050191

Reader Comments (1)

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FDA reports and publication bias

Posted by plosmedicine on 31 Mar 2009 at 00:30 GMT

Author: Fredric Cohen
Position: President
Institution: Pharma Growth Strategies LLC
E-mail: fred@pharmaweblog.com
Submitted Date: September 24, 2008
Published Date: September 29, 2008
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Lee et al are correct that current regulations will not ensure an absence of publication bias for US-approved drugs, as the minimum "basic results" required to be disclosed are not necessarily sufficient for making independent inferences of study results.

The logical solution is for legislators to mandate disclosure of complete study reports on the web immediately following marketing approval. The reports could be posted on a public site that allows for "peer review," much like PLoS offers this commenting opportunity.

Competing interests declared: I provide strategic management consulting services to life science companies and their service providers. I have never consulted for the FDA or a medical journal.