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- Title
Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
- Authors
Rising, Kristin; Bacchetti, Peter; Bero, Lisa
- Abstract
Previous studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the publication rate of efficacy trials submitted to the Food and Drug Administration (FDA) in approved New Drug Applications (NDAs) and to compare the trial characteristics as reported by the FDA with those reported in publications.
- Publication
PLoS medicine, 2008, Vol 5, Issue 11, pe217
- ISSN
1549-1676
- Publication type
Journal Article
- DOI
10.1371/journal.pmed.0050217