Allocating recycled significance levels in group sequential procedures for multiple endpoints

被引:19
|
作者
Xi, Dong [1 ]
Tamhane, Ajit C. [2 ]
机构
[1] Novartis Pharmaceut, IIS Stat Methodol, E Hanover, NJ 07936 USA
[2] Northwestern Univ, Dept Ind Engn & Management Sci, Evanston, IL 60208 USA
关键词
Error spending function; Familywise error rate; Graphical approach; O'Brien-Fleming boundary; Pocock boundary; Recycling; CLINICAL-TRIALS; ADAPTIVE EXTENSIONS; DESIGN;
D O I
10.1002/bimj.201300157
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Graphical approaches have been proposed in the literature for testing hypotheses on multiple endpoints by recycling significance levels from rejected hypotheses to unrejected ones. Recently, they have been extended to group sequential procedures (GSPs). Our focus in this paper is on the allocation of recycled significance levels from rejected hypotheses to the stages of the GSPs for unrejected hypotheses. We propose a delayed recycling method that allocates the recycled significance level from Stage r onward, where r is prespecified. We show that r cannot be chosen adaptively to coincide with the random stage at which the hypothesis from which the significance level is recycled is rejected. Such an adaptive GSP does not always control the FWER. One can choose r to minimize the expected sample size for a given power requirement. We illustrate how a simulation approach can be used for this purpose. Several examples, including a clinical trial example, are given to illustrate the proposed procedure.
引用
收藏
页码:90 / 107
页数:18
相关论文
共 50 条
  • [31] A NOTE ON SEQUENTIAL MULTIPLE DECISION PROCEDURES
    MEILIJSO.I
    [J]. ANNALS OF MATHEMATICAL STATISTICS, 1969, 40 (02): : 653 - &
  • [32] Improved group sequential Holm procedures for testing multiple correlated hypotheses over time
    Ohrn, Fredrik
    Niewczas, Julia
    Burman, Carl-Fredrik
    [J]. JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2022, 32 (02) : 230 - 246
  • [33] Resampling procedures to adjust for multiple endpoints in Quality of Life studies
    Fairclough, DL
    Wolfe, P
    [J]. CONTROLLED CLINICAL TRIALS, 2003, 24 : 77S - 78S
  • [34] Joint Hypothesis Testing and Gatekeeping Procedures for Studies with Multiple Endpoints
    Mascha, Edward J.
    Turan, Alparslan
    [J]. ANESTHESIA AND ANALGESIA, 2012, 114 (06): : 1304 - 1317
  • [35] OPTIMAL AND SUBOPTIMAL PROCEDURES IN GROUP SEQUENTIAL SAMPLING
    SPAHN, M
    EHRENFEL.S
    [J]. NAVAL RESEARCH LOGISTICS, 1974, 21 (01) : 53 - 68
  • [36] On group sequential procedures under variance heterogeneity
    Hussein, A
    Carriere, KC
    [J]. STATISTICAL METHODS IN MEDICAL RESEARCH, 2005, 14 (02) : 121 - 128
  • [37] A Bayesian two-stage group sequential scheme for ordinal endpoints
    Zhong, Chengxue
    Miao, Hongyu
    Pan, Haitao
    [J]. JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS, 2023, 72 (03) : 670 - 687
  • [38] Robust group sequential designs for trials with survival endpoints and delayed response
    Ghosh, Pranab
    Ristl, Robin
    Konig, Franz
    Posch, Martin
    Jennison, Christopher
    Goette, Heiko
    Schuler, Armin
    Mehta, Cyrus
    [J]. BIOMETRICAL JOURNAL, 2022, 64 (02) : 343 - 360
  • [39] On the power of some sequential multiple testing procedures
    Chen, Shiyun
    Arias-Castro, Ery
    [J]. ANNALS OF THE INSTITUTE OF STATISTICAL MATHEMATICS, 2021, 73 (02) : 311 - 336
  • [40] SEQUENTIAL PROCEDURES FOR MULTIPLE RESPONSES FACTOR SCREENING
    Wang, Wenyu
    Wan, Hong
    [J]. PROCEEDINGS OF THE 2014 WINTER SIMULATION CONFERENCE (WSC), 2014, : 745 - 756