Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration database.

ABSTRACT:

Background

Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.

Methods and findings

FDA Drug Approval Packages for eight second-generation antipsychotics-aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone--were used to identify a cohort of 24 FDA-registered premarketing trials. The resul

SUBMITTER: Turner EH 

PROVIDER: S-EPMC3308934 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature