Research misconduct goes unremarked in the peer-reviewed literature
A recent paper published by Charles Seife in JAMA Internal Medicine (April 2015) draws attention to serious integrity and communication issues affecting the biomedical research and publication pipeline. Seife’s statistics show that when the US Food and Drug Administration (FDA) finds significant departures from good clinical practice, those violations go most generally unnoticed in the resultant publications.
Based on documents issued by the FDA in 2013, Seife identified 57 published clinical trials linked to one or several severe violations during trial site inspection:
22 trials (39%) were linked to falsification or false information;
14 trials (25%) were linked to failures to report adverse events;
42 trials (74%) were linked to protocol violations;
35 trials (61%) were linked to inadequate or inaccurate recordkeeping;
30 trials (53%) were linked to safety problems and/or issues with oversight or informed consent;
and 20 trials (35%) were linked to violations otherwise categorized.
Those 57 clinical trials resulted in 78 articles published in the peer-reviewed literature. Of these 78 articles, only 3 publications (4%) included any mention of the FDA inspection violations, despite the fact that for 59 of those 78 articles (76%), the inspection was completed at least 6 months before the article was published.
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