Progress and challenges of confirmatory trials for cancer drugs granted conditional approval in China

被引:0
|
作者
Luo, Xingxian [1 ]
Xu, Yang [2 ,3 ]
Du, Xin [4 ]
Lv, Xufeng [5 ]
Chen, Si [5 ]
Yang, Yue [2 ,3 ]
Huang, Lin [1 ]
Zhang, Xiaohong [1 ]
机构
[1] Peking Univ, Dept Pharm, Peoples Hosp, Beijing, Peoples R China
[2] Tsinghua Univ, Sch Pharmaceut Sci, Beijing, Peoples R China
[3] Natl Med Prod Adm, Key Lab Innovat Drug Res & Evaluat, Beijing, Peoples R China
[4] Tsinghua Univ, Vanke Sch Publ Hlth, Beijing, Peoples R China
[5] Natl Med Prod Adm, Ctr Drug Evaluat, Beijing, Peoples R China
来源
基金
中国国家自然科学基金;
关键词
SURVIVAL; ONCOLOGY;
D O I
10.1016/j.lanwpc.2024.101238
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
引用
收藏
页数:5
相关论文
共 50 条
  • [1] Confirmatory Trials for Drugs Granted Conditional Approval by the Chinese National Medical Products Administration
    Tian, Yun
    Liu, Xiaoyong
    Liu, Xingyu
    Zhang, Jinwei
    Hu, Shuchen
    Yang, Caijun
    Fang, Yu
    JAMA HEALTH FORUM, 2024, 5 (12):
  • [2] 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
  • [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
    ECLINICALMEDICINE, 2023, 63
  • [4] Accelerated Approval Of Cancer Drugs: No Economic Reward For Drug Makers That Conduct Confirmatory Trials
    Frank, Richard G.
    Shahzad, Mahnum
    Emanuel, Ezekiel J.
    HEALTH AFFAIRS, 2022, 41 (09) : 1273 - 1280
  • [5] Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval
    Matsushita, Shunsuke
    Tachibana, Keisuke
    Kusakabe, Tetsuya
    Hirayama, Ryuichi
    Tsutsumi, Yasuo
    Kondoh, Masuo
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2021, 14 (03): : 806 - 811
  • [6] Confirmatory Trials of Accelerated Approval Drugs - Will Imposing Fines Reduce Delays?
    Daval, C. Joseph Ross
    Kesselheim, Aaron S.
    Scheffer Cliff, Edward R.
    NEW ENGLAND JOURNAL OF MEDICINE, 2024,
  • [7] Progress and Challenges of the New Conditional Approval Process in China: A Pooled Analysis From 2018 to 2021
    Li, Jinlian
    Wang, Haoyang
    Hua, Yanzhao
    Liu, Yue
    Chen, Yi
    Jiang, Rong
    Shao, Rong
    Xie, Jinping
    CLINICAL THERAPEUTICS, 2023, 45 (11) : 1111 - 1118
  • [8] The New Drug Conditional Approval Process in China: Challenges and Opportunities
    Yao, Xuefang
    Ding, Jinxi
    Liu, Yingfang
    Li, Penghui
    CLINICAL THERAPEUTICS, 2017, 39 (05) : 1040 - 1051
  • [9] Clinical Benefit, Price, and Regulatory Approval of Cancer Drugs Granted Breakthrough Therapy Designation in China, 2020-2024
    Luo, Xingxian
    Du, Xin
    Lv, Xufeng
    Yang, Yue
    Zhang, Xiaohong
    Huang, Lin
    JAMA NETWORK OPEN, 2024, 7 (10)
  • [10] Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective obser-vational study
    Gyawali, Bishal
    Rome, Benjamin N.
    Kesselheim, Aaron S.
    BMJ-BRITISH MEDICAL JOURNAL, 2021, 374