Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program

L Camille Jones; Sanket S Dhruva; Rita F Redberg

doi:10.1001/jamainternmed.2018.3649

Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program

JAMA Intern Med. 2018 Oct 1;178(10):1418-1420. doi: 10.1001/jamainternmed.2018.3649.

Authors

L Camille Jones¹, Sanket S Dhruva^{2

3}, Rita F Redberg^{4

5

6}

Affiliations

¹ University of California, San Francisco School of Medicine, San Francisco.
² Robert Wood Johnson Foundation Clinical Scholars Program, Yale University School of Medicine, New Haven, Connecticut.
³ Veterans Affairs Connecticut Healthcare System, New Haven, Connecticut.
⁴ Division of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco.
⁵ Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco School of Medicine, San Francisco.
⁶ Editor.

Abstract

This study uses publicly available FDA summaries to analyze the quality of evidence in pivotal studies that support cardiovascular premarket device approval under FDA priority review from 2007 to 2017.

MeSH terms

Cardiovascular Diseases / therapy*
Clinical Trials as Topic / standards*
Device Approval / standards*
Humans
United States
United States Food and Drug Administration*