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
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 50 条
  • [41] Surrogate Endpoints in Clinical Trials
    Elliott, Michael R.
    ANNUAL REVIEW OF STATISTICS AND ITS APPLICATION, 2023, 10 : 75 - 96
  • [42] ENDPOINTS FOR CLINICAL TRIALS OF SARCOIDOSIS
    Baughman, R. P.
    Drent, M.
    Culver, D. A.
    Grutters, J. C.
    Handa, T.
    Humbert, M.
    Judson, M. A.
    Lower, E. E.
    Mana, J.
    Pereira, C. A.
    Prasse, A.
    Sulica, R.
    Valyere, D.
    Vucinic, V.
    Wells, A. U.
    SARCOIDOSIS VASCULITIS AND DIFFUSE LUNG DISEASES, 2012, 29 (02) : 90 - 98
  • [43] Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations
    Turk, Dennis C.
    Dworkin, Robert H.
    McDermott, Michael P.
    Bellamy, Nicholas
    Burke, Laurie B.
    Chandler, Julie M.
    Cleeland, Charles S.
    Cowan, Penney
    Dimitrova, Rozalina
    Farrar, John T.
    Hertz, Sharon
    Heyse, Joseph F.
    Iyengar, Smriti.
    Jadad, Alejandro R.
    Jay, Gary W.
    Jermano, John A.
    Katz, Nathaniel P.
    Manning, Donald C.
    Martin, Susan
    Max, Mitchell B.
    McGrath, Patrick
    McQuay, Henry J.
    Quessy, Steve
    Rappaport, Bob A.
    Revicki, Dennis A.
    Rothman, Margaret
    Stauffer, Joseph W.
    Svensson, Ola
    White, Richard E.
    Witter, James
    PAIN, 2008, 139 (03) : 485 - 493
  • [44] A Test for Multiple Binary Endpoints with Continuous Latent Distribution in Clinical Trials
    Ishihara, Takuma
    Yamamoto, Kouji
    JOURNAL OF STATISTICAL THEORY AND APPLICATIONS, 2021, 20 (04): : 463 - 480
  • [45] Defining information fractions in group sequential clinical trials with multiple endpoints
    Xu, Tu
    Qin, Qin
    Wang, Xin
    CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, 2018, 10 : 77 - 79
  • [46] Resampling-based methods for the analysis of multiple endpoints in clinical trials
    Reitmeir, P
    Wassmer, G
    STATISTICS IN MEDICINE, 1999, 18 (24) : 3453 - 3462
  • [47] Testing multiple primary endpoints in clinical trials with sample size adaptation
    Liu, Yi
    Hu, Mingxiu
    PHARMACEUTICAL STATISTICS, 2016, 15 (01) : 37 - 45
  • [48] A Test for Multiple Binary Endpoints with Continuous Latent Distribution in Clinical Trials
    Takuma Ishihara
    Kouji Yamamoto
    Journal of Statistical Theory and Applications, 2021, 20 : 463 - 480
  • [49] Statistical planning in confirmatory clinical trials with multiple treatment groups, multiple visits, and multiple endpoints
    Sun, Hengrui
    Snyder, Ellen
    Koch, Gary G.
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2018, 28 (01) : 189 - 211
  • [50] Closed testing procedures for group sequential clinical trials with multiple endpoints
    Tang, DI
    Geller, NL
    BIOMETRICS, 1999, 55 (04) : 1188 - 1192