Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of... Key PointsQuestionWhat is the quality of clinical studies and data used to approve modifications to high-risk devices by the US Food and Drug Administration (FDA) panel-track supplement pathway? FindingsIn this descriptive study of 83 clinical studies for 78 panel-track supplements approved between 2006 and 2015, 45% were randomized clinical trials and 30% were blinded. Of the 150 primary end points in these studies, 81% were surrogates and 38% were compared with controls. MeaningThere are limitations in the quality of the studies and data evaluated by the FDA to support modifications of high-risk devices. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements

JAMA , Volume 318 (7) – Aug 15, 2017

Loading next page...
 
/lp/american-medical-association/characteristics-of-clinical-studies-used-for-us-food-and-drug-K8eUQjLzi0

References (22)

Publisher
American Medical Association
Copyright
Copyright 2017 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2017.9414
pmid
28810022
Publisher site
See Article on Publisher Site

Abstract

Key PointsQuestionWhat is the quality of clinical studies and data used to approve modifications to high-risk devices by the US Food and Drug Administration (FDA) panel-track supplement pathway? FindingsIn this descriptive study of 83 clinical studies for 78 panel-track supplements approved between 2006 and 2015, 45% were randomized clinical trials and 30% were blinded. Of the 150 primary end points in these studies, 81% were surrogates and 38% were compared with controls. MeaningThere are limitations in the quality of the studies and data evaluated by the FDA to support modifications of high-risk devices.

Journal

JAMAAmerican Medical Association

Published: Aug 15, 2017

There are no references for this article.