Tutorial in biostatistics - Sample sizes for clinical trials with normal data
Tutorial in biostatistics - Sample sizes for clinical trials with normal data
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DOI：
10.1002/sim.1783
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发表时间：
2004-06-30
影响因子：
2
通讯作者：
Julious, SA
中科院分区：
文献类型：
--
作者：
Julious, SA
本文概述了用正常数据进行平行组和交叉研究的样本量计算。样本大小推导给出了试验的目的是证明：优越性，等效性，非劣效性，生物等效性和估计给定的精度，不同类型的I和II错误。演示了不同的试验目标如何影响试验的零假设和备选假设，以及这些假设如何影响计算。给出了不同类型试验的样本量表和工作实例。版权所有：John Wiley Sons， Ltd. 2004
This article gives an overview of sample size calculations for parallel group and cross-over studies with Normal data. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non-inferiority, bioequivalence and estimation to a given precision, for different types I and II errors. It is demonstrated how the different trial objectives influence the null and alternative hypotheses of the trials and how these hypotheses influence the calculations. Sample size tables for the different types of trials and worked examples are given. Copyright (C) 2004 John Wiley Sons, Ltd.