Real-World Evidence - What Is It and What Can It Tell Us?

被引：1390

作者：

Sherman, Rachel E. ^{[1
,2
]}

Anderson, Steven A.

Dal Pan, Gerald J. ^{[4
]}

Gray, Gerry W. ^{[7
,8
]}

Gross, Thomas ^{[10
]}

Hunter, Nina L. ^{[1
,2
]}

LaVange, Lisa ^{[5
]}

Marinac-Dabic, Danica ^{[9
]}

Marks, Peter W. ^{[3
]}

Robb, Melissa A. ^{[6
]}

Shuren, Jeffrey ^{[11
]}

Temple, Robert ^{[3
]}

Woodcock, Janet ^{[3
]}

Yue, Lilly Q. ^{[7
,8
]}

Califf, Robert M. ^{[1
,2
]}

机构：

[1] US FDA, Off Commissioner, Silver Spring, MD USA

[2] US FDA, Off Biostat & Epidemiol, Silver Spring, MD USA

[3] US FDA, Off Ctr Director, Silver Spring, MD USA

[4] US FDA, Ctr Biol Evaluat & Res, Off Surveillance & Epidemiol, Silver Spring, MD USA

[5] US FDA, Off Biostat, Off Translat Sci, Silver Spring, MD USA

[6] US FDA, Off Med Policy, Silver Spring, MD USA

[7] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[8] US FDA, Div Biostat, Silver Spring, MD USA

[9] US FDA, Div Epidemiol, Silver Spring, MD USA

[10] US FDA, Off Surveillance & Biometr, Silver Spring, MD USA

[11] US FDA, Ctr Devices & Radiol Hlth, Off Ctr Director, Silver Spring, MD USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2016年 / 375卷 / 23期

关键词：

PRAGMATIC CLINICAL-TRIALS; REGULATORY ISSUES; APP;

D O I：

10.1056/NEJMsb1609216

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

[No abstract available]

引用

页码：2293 / 2297

页数：5

共 50 条