Zhang Jianliang, Zhang Jenny J
MedImmune, Gaithersburg, MD 20878, USA.
J Biopharm Stat. 2011 Jan;21(1):125-35. doi: 10.1080/10543401003642629.
This paper discusses multiple-to-one comparison trials testing a multivalent vaccine product against multiple comparators with respect to immunologic responses. An optimal subject allocation ratio between the multivalent vaccine group and any of the comparators is introduced. This optimal ratio leads to higher statistical efficiency in terms of savings in sample size compared to equal allocation or any other allocation ratios. Several trial design scenarios are considered including assumptions of equal standardized effect size, unequal variance, and unequal standardized effect sizes of the multivalent vaccines versus the multiple comparators.
本文讨论了在免疫反应方面针对多种对照物测试多价疫苗产品的多对一比较试验。引入了多价疫苗组与任何一种对照物之间的最佳受试者分配比例。与同等分配或任何其他分配比例相比,这种最佳比例在样本量节省方面带来了更高的统计效率。考虑了几种试验设计方案,包括多价疫苗与多种对照物的标准化效应大小相等、方差不相等以及标准化效应大小不相等的假设。