Outcome reporting in industry-sponsored trials of gabapentin for off-label use

Outcome reporting in industry-sponsored trials of gabapentin for off-label use

Vedula SS; Bero L; Scherer RW; Dickersin K

The New England Journal Of Medicine

2009

Humans; Treatment Outcome; Clinical Protocols; Pain/drug therapy; Migraine Disorders/drug therapy; Randomized Controlled Trials as Topic/standards; Publication Bias; Bipolar Disorder/drug therapy; Hal's Folder; Amines/therapeutic use; Cyclohexanecarboxylic Acids/therapeutic use; gamma-Aminobutyric Acid/therapeutic use; Off-Label Use/statistics & numerical data; Outcome Assessment (Health Care)/methods/standards

BACKGROUND: There is good evidence of selective outcome reporting in published reports of randomized trials. METHODS: We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports. RESULTS: We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. Sources of disagreement included the introduction of a new primary outcome (in the case of 6 trials), failure to distinguish between primary and secondary outcomes (2 trials), relegation of primary outcomes to secondary outcomes (2 trials), and failure to report one or more protocol-defined primary outcomes (5 trials). Trials that presented findings that were not significant (P > or = 0.05) for the protocol-defined primary outcome in the internal documents either were not reported in full or were reported with a changed primary outcome. The primary outcome was changed in the case of 5 of 8 published trials for which statistically significant differences favoring gabapentin were reported. Of the 21 primary outcomes described in the protocols of the published trials, 6 were not reported at all and 4 were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced. CONCLUSIONS: We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.

2009

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