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This is a freely accessible online resource for everyone involved in publication planning. Help us build the site into a valuable resource for, amongst others, medical writers and communications professionals, pharmaceutical industry managers, medical journal editors and publishers. Please send your ideas, contributions and comments about the articles to the Editor of The Publication Plan, Mary Greenacre. If you have any other comments about the service, the web site, or questions about advertising and sponsorship, please contact the Publisher, Peter Llewellyn.

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COMMENTARY << Selective publication

Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis Published 23 September 2008 PLoS Medicine reports an article showing that more than half of all studies of FDA-approved drugs remain unpublished 5 years after approval. The study also shows that pivotal trials and trials with statistically significant results and larger sample sizes are more likely to be published. [Link to original source material]

Commentary: Practicing on the Tip of an Information Iceberg? Evidence of Underpublication of Registered Clinical Trials in Oncology Published 15 September 2008 Article in The Oncologist on a study showing that less than one in five cancer studies registered with clinicaltrials.gov were published in peer-reviewed journals. [Link to original source material]

Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias Published 28 August 2008 This systematic review published by PLoS One reports that studies with positive or significant results are more likely to be published; statistically significant outcomes have higher odds of being fully reported; and publications are sometimes inconsistent with their protocols (primary outcome changed, introduced or omitted). [Link to original source material]

Selective publication of antidepressant trials and its influence on apparent efficacy Published 17 January 2008 This article in the NEJM describes a systematic literature search comparing availability of results from antidepressant trials in journal publications versus results provided to the FDA. The article concludes that more trials with positive results are published than those with negative or questionable results, but could not determine whether this occurred because investigators and/or sponsors chose not to submit for publication or because journal editors and reviewers decided against publication. [Link to original source material]

Concerns raised on delay of ezetimibe data Published 22 November 2007 This interview on theheart.org with Dr John Kastelein, the lead investigator of the ENHANCE study (ezetimibe plus simvastatin versus simvastatin alone), discusses reasons for the delay in publication of the study's results. [Link to original source material]

Cardiologists question delay of data on 2 drugs Published 21 November 2007 The delay in publishing results from ENHANCE, a trial comparing Schering-Plough/Merck's combination of simvastatin and ezetimibe with simvastatin alone, is discussed in this New York Times article from November 2007. [Link to original source material]

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