Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

被引:38
作者
Puthumana, Jeremy [1 ]
Wallach, Joshua D. [2 ]
Ross, Joseph S. [3 ]
机构
[1] Yale Sch Med, New Haven, CT USA
[2] Yale Univ, Collaborat Res Integr & Transparency, New Haven, CT USA
[3] Yale Sch Med, Dept Internal Med, New Haven, CT USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2018年 / 320卷 / 03期
基金
美国国家卫生研究院; 美国医疗保健研究与质量局;
关键词
D O I
10.1001/jama.2018.7619
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页码:301 / 303
页数:3
相关论文
共 6 条
  • [1] [Anonymous], Guidance for industry expedited programs for serious conditions-drugs and biologics
  • [2] Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
    Downing, Nicholas S.
    Aminawung, Jenerius A.
    Shah, Nilay D.
    Krumholz, Harlan M.
    Ross, Joseph S.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2014, 311 (04): : 368 - 377
  • [3] The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016
    Hwang, Thomas J.
    Darrow, Jonathan J.
    Kesselheim, Aaron S.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (21): : 2137 - 2138
  • [4] Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation
    Kesselheim, Aaron S.
    Woloshin, Steven
    Eddings, Wesley
    Franklin, Jessica M.
    Ross, Kathryn M.
    Schwartz, Lisa M.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 315 (14): : 1516 - 1518
  • [5] A Randomized Trial Testing US Food and Drug Administration "Breakthrough" Language
    Krishnamurti, Tamar
    Woloshin, Steven
    Schwartz, Lisa M.
    Fischhoff, Baruch
    [J]. JAMA INTERNAL MEDICINE, 2015, 175 (11) : 1856 - 1858
  • [6] WALLACH JD, 2018, BMJ, V361