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WHAT'S THIS?
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COMMENTARY << Selective publication
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Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes
Published 26 May 2010
Isabelle Boutron and colleagues report in JAMA how they looked for distorted presentation or "spin" in a representative sample of randomized controlled trials published in 2006 with statistically nonsignificant primary outcomes, and found that the reporting and interpretation of findings was frequently inconsistent with the results.
[Link to original source material]
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Why don’t we have all the evidence on oseltamivir?
Published 8 December 2009
This week the BMJ publishes an updated Cochrane review on neuraminidase inhibitors in adults with influenza. The review and a linked investigation undertaken jointly by the BMJ and Channel 4 News cast doubt not only on the effectiveness and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted. In her Editorial, Fiona Godlee, calls for more transparency and a focus on who has done what with the underlying data behind trial publications.
[Link to original source material]
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Pfizer critical of "selective outcome reporting" study
Published 12 November 2009
PharmaTimes reports Pfizer's comments on the NEJM article of 12 November which is claiming that Pfizer moved the goalposts and issued misleading data when it came to analyses of off-label use of its epilepsy drug Neurontin. Pfizer said "We believe the review suffers from significant bias, insufficient data, poor methodology and cannot pass the threshold of credible scientific research".
[Link to original source material]
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Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use
Published 12 November 2009
An article in The NEJM reports selective outcome reporting for trials of off-label use of gabapentin and concludes this practice threatens the validity of evidence for the effectiveness of off-label interventions.
[Link to original source material]
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Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Published 18 September 2009
An article published in PLoS by Joseph S. Ross and colleagues reports that a study showing that two-thirds of clinical trials included in the US national register had no record of their primary outcome suggests selective publication of trials remains a major problem in the healthcare arena.
[Link to original source material]
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Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
Published 2 September 2009
A paper in JAMA concludes that comparison of the primary outcomes of randomized controlled trials registered with their subsequent publication indicated that selective outcome reporting is prevalent.
[Link to original source material]
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German agency refuses to rule on drug’s benefits until Pfizer discloses all trial results
Published 22 June 2009
Ned Stafford reports in the BMJ, that an independent scientific institute that conducts healthcare research and evaluations mainly on behalf of Germany’s public health insurance regulator has accused the drug giant Pfizer of "concealing" research data on its depression treatment reboxetine.
[Link to original source material]
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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]
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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]
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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]
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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]
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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]
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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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