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Data in trials and their published papers do not always agree, finds analysis

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f809 (Published 06 February 2013) Cite this as: BMJ 2013;346:f809
  1. Bob Roehr
  1. 1Washington, DC

An analysis that compared clinical trial documents that were released because of a lawsuit with the corresponding papers published in medical journals has generated further concern about the integrity and reliability of research and of publishing.

The analysis, by researchers at Johns Hopkins University, Baltimore, and published in PLoS Medicine, was based on 21 trials of the off-label uses of gabapentin sponsored by the drug companies Pfizer and Parke-Davis.1 Only 11 of the trials were eventually published. But the extensive cache of documents was made public because of litigation over illegal marketing practices for the drug.

“For three trials there was disagreement on the number of randomized participants between the research report and publication,” summarized the senior …

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