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

被引:36
|
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
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 50 条
  • [1] Clinical trial evidence supporting FDA approval of novel orphan drugs between 2017 and 2023
    Chen, Qi
    Xu, Yang
    Qu, Ruoxuan
    Luo, Xingxian
    Yang, Yue
    [J]. DRUG DISCOVERY TODAY, 2024, 29 (09)
  • [2] Pharmacists' Knowledge and Perceptions of FDA Approval Standards and the Breakthrough Therapy Designation
    Herink, Megan C.
    Johnston, Kirbee
    Breninger, Kristin
    Wu, Erin
    Irwin, Adriane N.
    [J]. PHARMACY, 2022, 10 (05)
  • [3] Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022
    Luo, Xingxian
    Du, Xin
    Huang, Lin
    Guo, Qixiang
    Lv, Xufeng
    Wang, Cen
    Liu, Haopeng
    Zhou, Yue
    Xue, Xuecai
    Li, Zhuangqi
    Liu, Jingwen
    Chow, Shein-Chung
    Yang, Yue
    [J]. ECLINICALMEDICINE, 2023, 63
  • [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] US drugs were granted breakthrough approval on weak evidence, study finds
    Wise, Jacqui
    [J]. BMJ-BRITISH MEDICAL JOURNAL, 2018, 362
  • [6] Breakthrough therapy: FDA's new designation for accelerating approval of promising pipeline therapies
    Calabrese, David
    [J]. FORMULARY, 2013, 48 (08) : 275 - 276
  • [7] Magnitude of clinical benefit of trials supporting US Food and Drug Administration (FDA) approval of breakthrough and non-breakthrough drugs
    Molto Valiente, C.
    Borrell, M.
    Hwang, T.
    Gich Saladich, I.
    Barnadas, A.
    Amir, E.
    Kesselheim, A.
    Tibau, A.
    [J]. ANNALS OF ONCOLOGY, 2018, 29
  • [8] FDA Breakthrough Therapy Designation-Trial Design and More - Commentary
    Corrigan-Curay, Jacqueline
    Stein, Peter
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2021, 110 (04) : 869 - 870
  • [9] Breakthrough-Therapy Designation - An FDA Perspective
    Corrigan-Curay, Jacqueline
    Mckee, Amy E.
    Stein, Peter
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (15): : 1457 - 1458
  • [10] Rapastinel receives FDA breakthrough therapy designation
    不详
    [J]. NURSE PRACTITIONER, 2016, 41 (04): : 56 - 56