Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes

被引：20

作者：

Hamasaki, Toshimitsu ^{[1
]}

Asakura, Koko ^{[1
,2
]}

Evans, Scott R. ^{[3
,4
]}

Sugimoto, Tomoyuki ^{[5
]}

Sozu, Takashi ^{[6
]}

机构：

[1] Natl Cerebral & Cardiovasc Ctr, Biostat & Data Management, Suita, Osaka 5658565, Japan

[2] Osaka Univ, Grad Sch Med, Dept Innovat Clin Trials & Data Sci, Osaka, Japan

[3] Harvard Univ, TH Chan Sch Publ Hlth, Dept Biostat, Boston, MA 02115 USA

[4] Harvard Univ, TH Chan Sch Publ Hlth, Ctr Biostat AIDS Res, Boston, MA 02115 USA

[5] Hirosaki Univ, Grad Sch Sci & Technol, Dept Math Sci, Math Sci, Hirosaki, Aomori 0368561, Japan

[6] Kyoto Univ, Sch Publ Hlth, Dept Biostat, Biostat, Kyoto 6068501, Japan

来源：

STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2015年 / 7卷 / 01期

基金：

美国国家卫生研究院;

关键词：

Equally or unequally spaced increments of information; Adaptive Type I error allocation; Hierarchical testing procedure; Average sample number; Maximum sample size; PRIMARY END-POINTS; SAMPLE-SIZE DETERMINATION; DESIGN; POWER;

D O I：

10.1080/19466315.2014.1003090

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities, such as a varying number of analyses, equally or unequally spaced increments of information, and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, that is, potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints.

引用

页码：36 / 54

页数：19

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