Chen L, Tamura R N
Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA.
J Biopharm Stat. 1998 Mar;8(1):55-67. doi: 10.1080/10543409808835222.
In this paper, an exact test for analyzing the homogeneity of treatment effect in adaptive multicenter clinical trials is proposed. Extensive simulation studies are performed to investigate the large sample behavior of a commonly used test statistic for testing homogeneity of treatment effect. When the sample size in each center is large relative to the number of centers, the asymptotic null distribution of the test statistic is reasonable. On the other hand, when the data are relatively sparse, the proposed exact test should be used to incorporate the adaptive nature of the design.
本文提出了一种用于分析适应性多中心临床试验中治疗效果同质性的精确检验方法。进行了广泛的模拟研究，以考察用于检验治疗效果同质性的常用检验统计量的大样本行为。当每个中心的样本量相对于中心数量较大时，检验统计量的渐近零分布是合理的。另一方面，当数据相对稀疏时，应使用所提出的精确检验来纳入设计的适应性本质。
