Design and Analysis of Cross-Over Trials
Design and Analysis of Cross-Over Trials
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DOI：
10.2307/2532176
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发表时间：
1989-06
期刊：
影响因子：
--
通讯作者：
B. Jones;M. Kenward
中科院分区：
文献类型：
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作者：
B. Jones;M. Kenward
摘要 本章概述了交叉试验设计和分析的最新进展。我们首先考虑对两个时期的两种治疗方法 A 和 B 进行比较的试验分析，其中受试者被随机分配到治疗序列 AB 和 BA。我们区分了固定效应模型和随机效应模型，并展示了如何使用现代软件轻松拟合这些模型。描述了拟合和测试残留效应差异的问题，并讨论了基线测量的使用。还描述了当数据是二进制时测试处理差异的简单方法。然后描述和比较具有两个或多个治疗但具有三个或四个周期的各种设计。其中包括三种或更多处理的平衡和部分平衡设计以及因子处理组合的设计。还描述了近平衡和近强平衡设计。描述了两种或多种治疗设计的随机受试者效应模型，并给出了分析非正态数据的方法。本章最后描述了交叉设计在生物等效性测试中的使用。
Abstract This chapter provides an overview of recent developments in the design and analysis of cross-over trials. We first consider the analysis of the trial that compares two treatments, A and B, over two periods and where the subjects are randomized to the treatment sequences AB and BA. We make the distinction between fixed and random effects models and show how these models can easily be fitted using modern software. Issues with fitting and testing for a difference in carry-over effects are described and the use of baseline measurements is discussed. Simple methods for testing for a treatment difference when the data are binary are also described. Various designs with two or more treatments but with three or four periods are then described and compared. These include the balanced and partially balanced designs for three or more treatments and designs for factorial treatment combinations. Also described are nearly balanced and nearly strongly balanced designs. Random subject-effects models for the designs with two or more treatments are described and methods for analysing non-normal data are also given. The chapter concludes with a description of the use of cross-over designs in the testing of bioequivalence.