The US Food and Drug Administration's Real-World Evidence Framework: A Commitment for Engagement and Transparency on Real-World Evidence

被引：11
作者：
ElZarrad, M. Khair [1 ]
Corrigan-Curay, Jacqueline [1 ]
机构：
[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS | 2019年 / 106卷 / 01期
关键词：
D O I：
10.1002/cpt.1389
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
In December 2018, the US Food and Drug Administration (FDA) published a framework for its program to explore the use of real-world evidence to help support new indications for drugs that are already approved or to help support or satisfy postapproval study requirements. The framework reflects a larger initiative to explore and pilot the utility of a variety of evidence types and technological innovations that may enhance and accelerate drug development.
引用
收藏
页码：33 / 35
页数：3
相关论文
共 9 条
[1]  
[Anonymous], 2018, DAILY MED
[2]  
FDA, 2018, Framework for FDA's Real-World Evidence Program
[3]  
PEW Charitable Trust, 2018, MOB FACT SHEET
[4]   The FDA Sentinel Initiative - An Evolving National Resource [J].
Platt, Richard ;
Brown, Jeffrey S. ;
Robb, Melissa ;
McClellan, Mark ;
Ball, Robert ;
Nguyen, Michael D. ;
Sherman, Rachel E. .
NEW ENGLAND JOURNAL OF MEDICINE, 2018, 379 (22) :2091-2093
[5]  
US Food and Drug Administration, 2018, SENT IN
[6]  
US Food and Drug Administration, FDA GUID
[7]  
US Food and Drug Administration, 2017, SUPPL APPR LETT FDA
[8]  
US Food and Drug Administration, 2018, FDA BRIEF FDA LAUNCH
[9]   The HITECH Era and the Path Forward [J].
Washington, Vindell ;
DeSalvo, Karen ;
Mostashari, Farzad ;
Blumenthal, David .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (10) :904-906
1