Reporting of Trials of Gabapentin
To the Editor: In the Special Article on outcome reporting in industry-sponsored trials of gabapentin for off-label use, Vedula et al. (Nov. 12 issue) 1 claim to have identified unacceptable reporting practices in certain clinical trials. Our study on gabapentin for pain due to traumatic nerve injur...
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Published in | The New England journal of medicine Vol. 362; no. 17; pp. 1641 - 1642 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
United States
Massachusetts Medical Society
29.04.2010
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Subjects | |
Online Access | Get full text |
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Summary: | To the Editor:
In the Special Article on outcome reporting in industry-sponsored trials of gabapentin for off-label use, Vedula et al. (Nov. 12 issue)
1
claim to have identified unacceptable reporting practices in certain clinical trials.
Our study on gabapentin for pain due to traumatic nerve injury
2
was included as an example of disagreement between the definition of the primary outcome in the protocol and that in the published report. We strongly disagree.
New primary outcomes were not introduced in our published report. The primary-outcome variable (i.e., the mean visual-analogue score of the last week of each of the two treatment . . . |
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Bibliography: | SourceType-Other Sources-1 content type line 63 ObjectType-Correspondence-1 ObjectType-Commentary-2 |
ISSN: | 0028-4793 1533-4406 1533-4406 |
DOI: | 10.1056/NEJMc1000964 |