Regulatory Focus™ > News Articles > PLoS: Publication Bias Present for Antipsychotic Drugs

PLoS: Publication Bias Present for Antipsychotic Drugs

Posted 21 March 2012 | By

A study published in the journal Public Library of Science (PLoS) comparing published and unpublished US Food and Drug Administration (FDA)-registered clinical trials shows the presence of a modest publication bias in favor of antipsychotic drugs being seen as effective.

The study, conducted by a group of Oregon-based researchers, investigates whether or not unpublished studies were hiding data that could be seen as unfavorable to the drugs. The study compared 24 FDA-registered premarketing trials using eight second-generation antipsychotics, and compared the published and unpublished results of the trials. Four of the FDA-registered studies were unpublished.

"Three of these unpublished trials failed to show that the study drug was more effective than a placebo; the fourth showed that the study drug was inferior to another drug already in use in the US," wrote editor Peter C. Gøtzsche. "Among the 20 published trials, the five that the FDA judged not positive showed some evidence of publication bias."

The study was too small to say if the findings have any statistical significance.

Read more:

PLoS - Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database

Washington Post - Hidden data show that antipsychotic drugs are less effective than advertised

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