Sample Size Calculations In Clinical Research
Sample Size Calculations In Clinical Research
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DOI：
10.1201/9780203911341
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发表时间：
2007-04
期刊：
影响因子：
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通讯作者：
S. Chow;J. Shao;Hansheng Wang
中科院分区：
文献类型：
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作者：
S. Chow;J. Shao;Hansheng Wang
引言监管要求样本量计算的基本考虑程序样本量计算的目的和本书的结构样本量计算之前的考虑因素混杂和相互作用单侧检验与双侧检验交叉设计与平行设计亚组/中期分析数据转换实际问题比较平均值单样本设计双样本平行设计双样本交叉设计多样本单因素方差分析多样本单因素方差分析样本威廉姆斯设计实践问题比例的大样本检验单样本设计双样本平行设计双样本交叉设计单因素方差分析威廉姆斯设计相对风险-平行设计相对风险-交叉设计实践问题比例的精确检验二项式检验Fisher精确检验单臂试验的最优多阶段设计多阶段灵活设计组间试验备注拟合优度和偶然性表的检验拟合优度独立性检验独立性的单层检验分类转移传递效应检验的多层检验实际问题比较事件发生时间数据基本概念指数模型考克斯比例风险模型加权对数秩检验实际问题分组序贯方法波考克检验奥布莱恩和弗莱明检验Wang和Tsiatis检验内楔检验二进制变量事件发生时间数据α消耗函数样本量Re-估计条件功效实际问题比较变量比较受试者内变量比较受试者内CV比较受试者间变量比较总变量实际问题生物等效性检验生物等效性标准平均生物等效性群体生物等效性个体生物等效性体外生物等效性非参数违反假设1-样本定位问题双样本定位问题独立性检验实践问题其他领域样本量计算剂量反应研究重复测量方差分析生活质量桥接研究疫苗临床试验附录：分位数表参考索引
INTRODUCTION Regulatory Requirement Basic Considerations Procedures for Sample Size Calculation Aims and Structure of the Book CONSIDERATIONS PRIOR TO SAMPLE SIZE CALCULATION Confounding and Interaction One-Sided Test Versus Two-Sided Test Crossover Design Versus Parallel Design Subgroup/Interim Analyses Data Transformation Practical Issues COMPARING MEANS One-Sample Design Two-Sample Parallel Design Two-Sample Crossover Design Multiple-Sample One-Way ANOVA Multiple-Sample Williams Design Practical Issues LARGE SAMPLE TESTS FOR PROPORTIONS One-Sample Design Two-Sample Parallel Design Two-Sample Crossover Design One-Way Analysis of Variance Williams Design Relative Risk - Parallel Design Relative Risk - Crossover Design Practical Issues EXACT TESTS FOR PROPORTIONS Binomial Test Fisher's Exact Test Optimal Multiple-Stage Designs for Single Arm Trials Flexible Designs for Multiple-Arm Trials Remarks TESTS FOR GOODNESS-OF-FIT AND CONTINGENCY TABLES Tests for Goodness-of-Fit Test for Independence -Single Stratum Test for Independence -Multiple Strata Test for Categorical Shift Carry-Over Effect Test Practical Issues COMPARING TIME-TO-EVENT DATA Basic Concepts Exponential Model Cox's Proportional Hazards Model Weighted Log-Rank Test Practical Issues GROUP SEQUENTIAL METHODS Pocock's Test O'Brien and Fleming's Test Wang and Tsiatis' Test Inner Wedge Test Binary Variables Time-to-Event Data Alpha Spending Function Sample Size Re-Estimation Conditional Power Practical Issues COMPARING VARIABILITIES Comparing Intra-Subject Variabilities Comparing Intra-Subject CVs Comparing Inter-Subject Variabilities Comparing Total Variabilities Practical Issues BIOEQUIVALENCE TESTING Bioequivalence Criteria Average Bioequivalence Population Bioequivalence Individual Bioequivalence In Vitro Bioequivalence NONPARAMETRICS Violation of Assumptions One-Sample Location Problem Two-Sample Location Problem Test for Independence Practical Issues SAMPLE SIZE CALCULATION IN OTHER AREAS Dose Response Studies ANOVA with Repeated Measures Quality of Life Bridging Studies Vaccine Clinical Trials Appendix: Tables of Quantiles References Index