Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

ABSTRACT:

Background

Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry.

Methods

Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA. For published trials, we compared the published interpretation of the findings (positive, equivocal, or negative) with the FDA reviewer's interpretation.

Results

B

SUBMITTER: Phillips AT 

PROVIDER: S-EPMC5516301 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature