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Research Article

Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation

  • Kristin Rising,

    Affiliation: School of Medicine, University of California San Francisco, San Francisco, California, United States of America

    ยค Current address: Department of Internal Medicine, Boston Medical Center, Boston, Massachusetts, United States of America

    X
  • Peter Bacchetti,

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

    X
  • Lisa Bero mail

    To whom correspondence should be addressed. E-mail: berol@pharmacy.ucsf.edu

    Affiliation: Clinical Pharmacy and Health Policy, University of California San Francisco, San Francisco, California, United States of America

    X
  • Published: November 25, 2008
  • DOI: 10.1371/journal.pmed.0050217

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News Coverage

Posted by plosmedicine on 31 Mar 2009 at 00:33 GMT

Author: Nisha Doshi
Position: Publications Assistant
Institution: PLoS Medicine
E-mail: ndoshi@plos.org
Submitted Date: December 18, 2008
Published Date: December 18, 2008
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

In a paper about publication bias among trials submitted to the Food and Drug Adminstration, Lisa Bero and colleagues found that a quarter of trials submitted in support of new drugs applications remain unpublished a year after the fact. The study also found that among the published results, unexplained discrepancies between the FDA submission and the published studies tended to lead to more favourable presentations of the drugs.

A summary of the news coverage of this paper can be found in Andrew Hyde's blog: http://www.plos.org/cms/n...

Since Andrew wrote his blog post, further coverage has included:
Gooznews: http://www.gooznews.com/a...
San Francisco Chronicle: http://www.sfgate.com/cgi...

No competing interests declared.