A note on sample size calculation for mean comparisons based on noncentral t-statistics.
A note on sample size calculation for mean comparisons based on noncentral t-statistics.
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DOI：
10.1081/bip-120016229
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发表时间：
2002-11-01
影响因子：
1.1
通讯作者：
Wang, Hansheng
中科院分区：
文献类型：
--
作者：
Chow, Shein-Chung;Shao, Jun;Wang, Hansheng
单样本和双样本t检验通常用于分析临床试验数据，以比较两种药物产品的平均响应。在临床研究的计划阶段，关键的一步是样本量的计算，即，确定实现期望功率所需的对象（患者）的数量（例如，80%），用于检测平均药物反应的临床有意义的差异。基于非中心t分布，我们推导了在单样本设计、双样本平行设计和双样本交叉设计下检验等效性、检验治疗非劣效性/优效性和检验治疗等效性的样本量计算公式。构造了一些有用的表格，并给出了一些示例。
One-sample and two-sample t-tests are commonly used in analyzing data from clinical trials in comparing mean responses from two drug products. During the planning stage of a clinical study, a crucial step is the sample size calculation, i.e., the determination of the number of subjects (patients) needed to achieve a desired power (e.g., 80%) for detecting a clinically meaningful difference in the mean drug responses. Based on noncentral t-distributions, we derive some sample size calculation formulas for testing equality, testing therapeutic noninferiority/superiority, and testing therapeutic equivalence, under the popular one-sample design, two-sample parallel design, and two-sample crossover design. Useful tables are constructed and some examples are given for illustration.