Healthy Skepticism Library item: 14681

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Rising K, Bacchetti P, Bero L.
Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation
PLoS Med 2008 Apr 28; 5:(11):
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0050217

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.