Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US

被引：3
|
作者：
Jazowski, Shelley A. [1 ,5 ]
Vaidya, Avi U. [1 ]
Donohue, Julie M. [2 ]
Dusetzina, Stacie B. [1 ,3 ]
Sachs, Rachel E. [4 ]
机构：
[1] Vanderbilt Univ, Sch Med, Dept Hlth Policy, Nashville, TN USA
[2] Univ Pittsburgh, Sch Publ Hlth, Dept Hlth Policy & Management, Pittsburgh, PA USA
[3] Vanderbilt Ingram Canc Ctr, Nashville, TN USA
[4] Washington Univ St Louis, Sch Law, St Louis, MO USA
[5] Vanderbilt Univ, Sch Med, Dept Hlth Policy, 2525 West End Ave,Ste 1200, Nashville, TN 37203 USA
来源：
JAMA INTERNAL MEDICINE | 2023年 / 183卷 / 07期
基金：
美国医疗保健研究与质量局;
关键词：
D O I：
10.1001/jamainternmed.2023.0777
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
This cross-sectional study examines and compares the time taken from the accelerated approval of cancer and noncancer drugs to the initiation of confirmatory studies in the US.
引用
收藏
页码：737 / 739
页数：3
相关论文
共 50 条
  • [21] ARE ACCELERATED APPROVAL MECHANISMS A PREDICTOR TO EARLY ACCESS AND COVERAGE? A GLOBAL STUDY OF CANCER DRUGS
    Tzouma, V
    Efthymiadou, O.
    Mills, M.
    Kanavos, P.
    VALUE IN HEALTH, 2017, 20 (09) : A458 - A458
  • [22] The Accelerated Approval Program for Cancer Drugs - Finding the Right Balance
    Gyawali, Bishal
    Kesselheim, Aaron S.
    Ross, Joseph S.
    NEW ENGLAND JOURNAL OF MEDICINE, 2023, 389 (11): : 968 - 971
  • [23] Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval
    Gyawali, Bishal
    Hey, Spencer Phillips
    Kesselheim, Aaron S.
    JAMA INTERNAL MEDICINE, 2019, 179 (07) : 906 - 913
  • [24] Progress and challenges of confirmatory trials for cancer drugs granted conditional approval in China
    Luo, Xingxian
    Xu, Yang
    Du, Xin
    Lv, Xufeng
    Chen, Si
    Yang, Yue
    Huang, Lin
    Zhang, Xiaohong
    LANCET REGIONAL HEALTH-WESTERN PACIFIC, 2024, 52
  • [25] Approval and Coverage of Cancer Drugs in England, Canada, and the US
    Prasad, Vinay
    Kim, Myung S.
    JAMA INTERNAL MEDICINE, 2021, 181 (04) : 509 - 510
  • [26] Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
    Deshmukh, Anjali D.
    Kesselheim, Aaron S.
    Rome, Benjamin N.
    JAMA HEALTH FORUM, 2023, 4 (03): : E230217
  • [27] Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs
    Kraus, V. B.
    Simon, L. S.
    Katz, J. N.
    Neogi, T.
    Hunter, D.
    Guermazi, A.
    Karsdal, M. A.
    OSTEOARTHRITIS AND CARTILAGE, 2019, 27 (04) : 571 - 579
  • [28] National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval
    Cliff, Edward R. Scheffer
    Rome, Rachel S.
    Kesselheim, Aaron S.
    Rome, Benjamin N.
    JAMA NETWORK OPEN, 2023, 6 (11) : E2343285
  • [29] Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval
    Oda, Yoshihiro
    Narukawa, Mamoru
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2024, 58 (02) : 387 - 394
  • [30] Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval
    Yoshihiro Oda
    Mamoru Narukawa
    Therapeutic Innovation & Regulatory Science, 2024, 58 : 387 - 394
12345