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

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. Using...

Full description

Saved in:

Bibliographic Details
Published in:	Current controlled trials in cardiovascular medicine 2017-07, Vol.18 (1), p.333-333, Article 333
Main Authors:	Phillips, Adam T, Desai, Nihar R, Krumholz, Harlan M, Zou, Constance X, Miller, Jennifer E, Ross, Joseph S
Format:	Article
Language:	eng
Subjects:	Cardiovascular disease Clinical trials Corporate sponsorship Diabetes Drug approval Drugs FDA approval Laws, regulations and rules Registration Review Statistics United States Food and Drug Administration
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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. 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. Between 2005 and 2014, the FDA approved 30 drugs for 32 indications of cardiovascular disease (n = 17) and diabetes (n = 15) on the basis of 183 trials (median per indication 5.7 (IQR, 3-8)). Compared with pre FDAAA, post-FDAAA studies were more likely to be registered (78 of 78 (100%) vs 73 of 105 (70%); p
ISSN:	1745-6215 1745-6215 1468-6694