Sample Size Determination in Superiority Clinical Trials with Multiple Co-Primary Correlated Endpoints
Sample Size Determination in Superiority Clinical Trials with Multiple Co-Primary Correlated Endpoints
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DOI：
10.1080/10543406.2011.551329
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发表时间：
2011-01-01
影响因子：
1.1
通讯作者：
Hamasaki, Toshimitsu
中科院分区：
文献类型：
--
作者：
Sozu, Takashi;Sugimoto, Tomoyuki;Hamasaki, Toshimitsu
在药物开发中，出于监管目的，越来越多的讨论涉及建立统计学显著性结果，以证明新治疗对多个协同主要终点的疗效。在具有多个协同主要终点的设计阶段，关键是确定适当的样本量，以表明所有协同主要终点的统计学显著性，同时保留预期的把握度集，因为II类错误随着协同主要终点数量的增加而增加。我们提供了多个共同主要终点的功效和样本量计算的基本公式，并通过数值表格和示例说明了所提供方法的方面。
In pharmaceutical drug development, for regulatory purposes, there are increasing discussions on the establishment of statistically significant results demonstrating the efficacy of a new treatment on multiple co-primary endpoints. At the design stage with multiple co-primary endpoints, it is critical to determine the appropriate sample size for indicating statistical significance for all co-primary endpoints with preserving the intended power set, since the type II error increases as the number of co-primary endpoints increases. We provide fundamental formulae for power and sample size calculation with multiple co-primary endpoints and illustrate the aspect of the provided methods through numerical tables and examples.