Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.

ABSTRACT:

Background

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.

Methods and findings

This is an observational study of all efficacy trials found in approved NDAs for New Molecular Entities (NMEs) from 2001 to 2002 inclusive and all published clinical trials corresponding to the trials within the NDAs. For each trial included in the NDA, we assessed its publication status, primary outcome(s) reported and thei

SUBMITTER: Rising K 

PROVIDER: S-EPMC2586350 | biostudies-literature | 2008 Nov

REPOSITORIES: biostudies-literature