Evidence Strength in FDA Premarket Approval of Cardiovascular Devices

被引:1
作者
Kong, David F. [1 ]
Hasselblad, Vic [1 ]
Krucoff, Mitchell W. [1 ]
机构
[1] Duke Clin Res Inst, Durham, NC USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2010年 / 303卷 / 16期
关键词
D O I
10.1001/jama.2010.511
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页码:1599 / 1600
页数:2
相关论文
共 5 条
[1]   Late thrombosis of drug-eluting stents: A meta-analysis of randomized clinical trials [J].
Bavry, Anthony A. ;
Kumbhani, Dharam J. ;
Helton, Thomas J. ;
Borek, Przemyslaw P. ;
Mood, Girish R. ;
Bhatt, Deepak L. .
AMERICAN JOURNAL OF MEDICINE, 2006, 119 (12) :1056-1061
[2]   FDA perspective on clinical trial design for cardiovascular devices [J].
Chen, Eric ;
Sapirstein, Wolf ;
Ahn, Chul ;
Swain, Julie ;
Zuckerman, Bram .
ANNALS OF THORACIC SURGERY, 2006, 82 (03) :773-775
[3]   Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices [J].
Dhruva, Sanket S. ;
Bero, Lisa A. ;
Redberg, Rita F. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2009, 302 (24) :2679-2685
[4]   How FDA currently makes decisions on clinical studies [J].
Temple, R .
CLINICAL TRIALS, 2005, 2 (04) :276-281
[5]  
US FDA, GUID US BAYES STAT M