Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints

被引：0
|
作者：
Luo, Xiaodong [1 ]
Quan, Hui [1 ]
机构：
[1] Sanofi US, Biostat & Programming, 55 Corp Dr, Bridgewater, NJ 08807 USA
来源：
STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2024年 / 16卷 / 01期
关键词：
Generalized Simes inequality; Group-sequential p-values; Multiplicity; q-values; early submission; alpha-propagation; BONFERRONI PROCEDURE; TESTS;
D O I：
10.1080/19466315.2023.2191989
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
This article proposes some new multiplicity adjustment procedures for clinical trials with multiple endpoints and multiple interim analyses. The proposed sequential procedures, adapting the popular multiple comparison procedures for fixed time-point design and using a-spending for each endpoint, are shown to strongly control the family-wise Type-1 error rate and provide powerful yet versatile multiplicity adjustment solutions for monitoring multiple endpoints via interim analyses.
引用
收藏
页码：104 / 115
页数：12
相关论文
共 50 条
  • [21] Novel Procedures for Validating Surrogate Endpoints in Clinical Trials
    Cleophas, Ton J.
    Zwinderman, Aeilko H.
    Chaib, Amel H.
    CURRENT CLINICAL PHARMACOLOGY, 2007, 2 (02): : 123 - 128
  • [22] How to deal with multiple endpoints in clinical trials
    Neuhaeuser, Markus
    FUNDAMENTAL & CLINICAL PHARMACOLOGY, 2006, 20 (06) : 515 - 523
  • [23] Workshop on the design and use of clinical trials with multiple endpoints, with a focus on prevention of RSV
    Prunas, O.
    Willemsen, J.
    Warren, J. L.
    Bont, L.
    Schwartz, J. L.
    Atwell, J.
    Begier, E.
    Dean, N.
    Hirsch, I.
    Karron, R.
    Klugman, K.
    Kramer, R.
    Leidman, E.
    Link-Gelles, R.
    Nair, H.
    Panozzo, CA.
    Pelfrene, E.
    Simoes, E. A. F.
    Smith, P. G.
    Srikantiah, P.
    Sundaram, M. E.
    Thindwa, D.
    Vaughn, D. W.
    Wilson, E.
    Zar, H. J.
    Pitzer, V. E.
    Weinberger, D. M.
    VACCINE: X, 2024, 19
  • [24] Hierarchical testing of multiple endpoints in group-sequential trials
    Glimm, Ekkehard
    Maurer, Willi
    Bretz, Frank
    STATISTICS IN MEDICINE, 2010, 29 (02) : 219 - 228
  • [25] Some issues with composite endpoints in clinical trials
    Chi, GYH
    FUNDAMENTAL & CLINICAL PHARMACOLOGY, 2005, 19 (06) : 609 - 619
  • [26] Adaptive Multiple Comparison Sequential Design (AMCSD) for clinical trials
    Gao, Ping
    Li, Yingqiu
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2024, 34 (03) : 424 - 440
  • [27] Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues
    Sankoh, AJ
    D'Agostino, RB
    Huque, MF
    STATISTICS IN MEDICINE, 2003, 22 (20) : 3133 - 3150
  • [28] Multiplicity of inferences in clinical trials: adjustment methods, clinical interpretation issues
    Jouan-Flahault, C
    Casset-Semanaz, F
    Minini, P
    M S-MEDECINE SCIENCES, 2004, 20 (02): : 231 - 235
  • [29] Design and Endpoints of Clinical Trials, Current and Future
    Sherman, Morris
    DIGESTIVE DISEASES AND SCIENCES, 2019, 64 (04) : 1050 - 1057
  • [30] Clinical trials: design, endpoints and interpretation of outcomes
    Megan Othus
    Mei-Jie Zhang
    Robert Peter Gale
    Bone Marrow Transplantation, 2022, 57 : 338 - 342
12345