Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan

被引：0
作者：
Kentaro Sakamaki
Seitaro Yoshida
Yusuke Morita
Toshifumi Kamiura
Katsuhiro Iba
Naoyuki Ogawa
Hideki Suganami
Satoru Tsuchiya
Satoru Fukimbara
机构：
[1] The University of Tokyo,Department of Biostatistics and Bioinformatics
[2] Yokohama City University,Center for Data Science
[3] Japan Pharmaceutical Manufacturers Association,Data Science Expert Committee, Drug Evaluation Committee
[4] Chugai Pharmaceutical Co,Clinical Information & Intelligence Department
[5] Ltd,Clinical Data Science and Affairs
[6] Kyorin Pharmaceutical Co,Data Science Department
[7] Ltd,Department of Biometrics
[8] Nippon Shinyaku Co,Clinical Development Department
[9] Ltd,Clinical Data Science Department
[10] Otsuka Pharmaceutical Co,Data Science
[11] Ltd,Data Science
[12] Sanwa Kagaku Kenkyusho Co,undefined
[13] Ltd,undefined
[14] Kowa Company,undefined
[15] Ltd,undefined
[16] Sumitomo Dainippon Pharma Co,undefined
[17] Ltd,undefined
[18] Ono Pharmaceutical Co,undefined
[19] Ltd,undefined
来源：
Therapeutic Innovation & Regulatory Science | 2020年 / 54卷
关键词：
multiple endpoints; terminology; determination of endpoint; multiplicity adjustment; industry survey;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：528 / 533
页数：5
相关论文
共 37 条
  • [21] Management of the IT industry: A survey of critical challenges
    Fry, MR
    AUSTRALIAN COMPUTER JOURNAL, 1996, 28 (03): : 88 - 95
  • [22] Multi-arm trials with multiple primary endpoints and missing values
    Hasler, Mario
    Hothorn, Ludwig A.
    STATISTICS IN MEDICINE, 2018, 37 (05) : 710 - 721
  • [23] Superiority Inferences on Individual Endpoints Following Noninferiority Testing in Clinical Trials
    Logan, Brent R.
    Tamhane, Affit C.
    BIOMETRICAL JOURNAL, 2008, 50 (05) : 693 - 703
  • [24] Analysis of phase II methodologies for single-arm clinical trials with multiple endpoints in rare cancers: An example in Ewing's sarcoma
    Dutton, P.
    Love, S. B.
    Billingham, L.
    Hassan, A. B.
    STATISTICAL METHODS IN MEDICAL RESEARCH, 2018, 27 (05) : 1451 - 1463
  • [25] Optimal multiple testing and design in clinical trials
    Heller, Ruth
    Krieger, Abba
    Rosset, Saharon
    BIOMETRICS, 2023, 79 (03) : 1908 - 1919
  • [26] UNDERSTANDING THE NATURE OF TREATMENT EFFECTS OF MULTIPLE ENDPOINTS OF A CLINICAL TRIAL USING BOOTSTRAP
    Rashid, Mushfiqur
    Huque, M. F.
    JP JOURNAL OF BIOSTATISTICS, 2009, 3 (02) : 145 - 169
  • [27] Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints
    Asakura, Koko
    Hamasaki, Toshimitsu
    Evans, Scott R.
    BIOMETRICAL JOURNAL, 2017, 59 (04) : 703 - 731
  • [28] Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials
    Hung, H. M. James
    Wang, Sue-Jane
    Yang, Peiling
    Jin, Kun
    Lawrence, John
    Kordzakhia, George
    Massie, Tristan
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2016, 26 (01) : 37 - 43
  • [29] Design of clinical trials with failure-time endpoints and interim analyses: An update after fifteen years
    He, Pei
    Lai, Tze Leung
    Su, Zheng
    CONTEMPORARY CLINICAL TRIALS, 2015, 45 : 103 - 112
  • [30] A marginal rank-based inverse normal transformation approach to comparing multiple clinical trial endpoints
    Cai, Xiaoyu
    Li, Huiyun
    Liu, Aiyi
    STATISTICS IN MEDICINE, 2016, 35 (19) : 3259 - 3271
1234