Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk

被引：6
作者：
Califf, Robert M. [1 ,2 ,3 ]
机构：
[1] Duke Hlth, Durham, NC USA
[2] Duke Univ, Sch Med, Ste 401,Davison Bldg,100 Trent Dr, Durham, NC 27710 USA
[3] Verily Life Sci, San Francisco, CA USA
来源：
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2017年 / 318卷 / 07期
基金：
美国国家卫生研究院;
关键词：
D O I：
10.1001/jama.2017.9412
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页码：614 / 616
页数：3
相关论文
共 7 条
  • [1] [Anonymous], 2014, Guidance for Industry: Expedited Programs for Serious Conditions Drugs and Biologics
  • [2] A Controlled Trial of Renal Denervation for Resistant Hypertension
    Bhatt, Deepak L.
    Kandzari, David E.
    O'Neill, William W.
    D'Agostino, Ralph
    Flack, John M.
    Katzen, Barry T.
    Leon, Martin B.
    Liu, Minglei
    Mauri, Laura
    Negoita, Manuela
    Cohen, Sidney A.
    Oparil, Suzanne
    Rocha-Singh, Krishna
    Townsend, Raymond R.
    Bakris, George L.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (15) : 1393 - 1401
  • [3] Surrogate end points in clinical trials: Are we being misled?
    Fleming, TR
    DeMets, DL
    [J]. ANNALS OF INTERNAL MEDICINE, 1996, 125 (07) : 605 - 613
  • [4] Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration
    Naci, Huseyin
    Smalley, Katelyn R.
    Kesselheim, Aaron S.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (07): : 626 - 636
  • [5] Accelerating development of scientific evidence for medical products within the existing US regulatory framework
    Sherman, Rachel E.
    Davies, Kathleen M.
    Robb, Melissa A.
    Hunter, Nina L.
    Califf, Robert M.
    [J]. NATURE REVIEWS DRUG DISCOVERY, 2017, 16 (05) : 297 - 298
  • [6] Need for a National Evaluation System for Health Technology
    Shuren, Jeffrey
    Califf, Robert M.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 316 (11): : 1153 - 1154
  • [7] Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
    Zheng, Sarah Y.
    Dhruva, Sanket S.
    Redberg, Rita F.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (07): : 619 - 625
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