Cross-over trials in clinical research临床研究交叉试验（第2版） 下载 pdf 百度网盘 epub 免费 2025 电子版 mobi 在线

Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages.

Comprehensive coverage of the design and analysis of cross-over trials.

Each technique is carefully explained and the mathematics is kept to a minimum.

Features many real and original examples, taken from the author's vast experience.

Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel.

Written in a style suitable for statisticians and physicians alike.

Computer programs to accompany the examples in the book can be downloaded from the Web

Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.

Preface to the second edition

Preface to the first edition

1 Introduction

　1.1 The purpose of this chapter

　1.2 An example

　1.3 Why are cross-over trials performed?

　1.4 Whal are the disadvantages of cross-over trials?

　1.5 Where are cross-over trials useful?

　1.6 What attitude to cross-over trials will be adopted in this book?

　1.7 Carry-over

　1.8 What may be done about carry-over?

　1.9 Other attitudes to be adopted

　1.10 Where else can one find out about cross-over trials?

2　Some basic considerations concerning estimation in clinical trials

　2.1 The purpose of this chapter

　2.2 Assumed background knowledge

　2.3 Control in clinical trials

　2.4 Two purposes of estimation

　2.5 Some features of estimation

　2.6 Practical consequences for cross-over trials

3 The AB/BA design with Normal data

　3.1 An example

　3.2 A simple analysis ignoring the effect of period

　3.3 Student's approach

　3.4 Assumptions in the matched-pairs t approach

　3.5 Adjusting for a period effect: two-sample t approach

　3.6 Adjusting for a period effect: the Hills-Armitage approach

　3.7 Examining period effects

　3.8 Testing for carry-over and/or treatment by period interaction

　3.9 A model for the AB/BA cross-over

　3.10 Carry-over or treatment by period interaction?

　3.11 Confidence intervals for carry-over

　3.12 Are unbiased estimators of the treatment effect available?

　3.13 Can we adjust for carw-over

　3.14 The two-stage analysis

　3.15 Correcting the two-stage procedure

　3.16 Use of baseline measurements

　3.17 A Bayesian approach

　3.18 Computer analysis

　3.19 Further reading

　3.20 Recommendations

　Appendix 3.1 Analysis with GenStat

　Appendix 3.2 Analysis with S-Plus

4 Other outcomes and the AB/BA design

　4.1 Introduction

　4.2 Transformations

　4.3 Non-parametric methods

　4.4 Binary outcomes

　4.5 Ordered categorical data

　4.6 Frequency data

　4,7 'Survival' data

　4.8 Final remarks

　Appendix 4.1 Analysis with GenStat

　Appendix 4.2 Analysis with S-Plus

5　Normal data from designs with three or more treatments

　5.1 Why do we have designs with three or more treatments?

　5.2 Sequences for trials with three or more treatments

　5.3 Analyses ignoring the effect of period

　5.4 Allowing for period effects

　5.5 Other miscellaneous issues

　5.6 Recommendations

　Appendix 5.1 Analysis with GenStat

　Appendix 5.2 Analysis with S-Plus

6 Other outcomes from designs with three or more treatments

　6.1 Introduction

　6.2 Analyses which take no account of period effects

　6.3 Non-parametric analyses adjusting for period effects

　6,4 Hodges-Lehmann type estimators

　6.5 A stratified period adjusted sign test

　6.6 Binary data

　6.7 Other analyses

　Appendix 6.1 Analysis with GenStat

　Appendix 6.2 Analysis with S-Plus

7 Some special designs

8 Graphical and tabular presentation of cross-over trials

9 Various design issues

10 Mathematical approaches to carry-over

References

Author index

Subject index

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书籍介绍

Cross--over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross--over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross--over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. Comprehensive coverage of the design and analysis of cross--over trials. Each technique is carefully explained and the mathematics is kept to a minimum. Features many real and original examples, taken from the author's vast experience. Includes discussion of analysis using SAS, S--Plus and, GenStat, StatXact and Excel. Written in a style suitable for statisticians and physicians alike. Computer programs to accompany the examples in the book can be downloaded from the Web Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.