| 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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