Cross over trials in clinical research:
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Chichester [u.a.]
Wiley
2002
|
| Edition: | 2. ed. |
| Series: | Statistics in practice
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XV, 345 S. graph. Darst. |
| ISBN: | 0471496537 |
Staff View
MARC
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Record in the Search Index
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|---|---|
| adam_text | Contents
Preface to the second edition ix
Preface to the first edition xiii
1 Introduction 1
1.1 The purpose of this chapter 1
1.2 An example 1
1.3 Why are cross over trials performed? 5
1.4 What are the disadvantages of cross over trials? 7
1.5 Where are cross over trials useful? 9
1.6 What attitude to cross over trials will be adopted in this book? 9
1.7 Carry over 10
1.8 What may be done about carry over? 11
1.9 Other attitudes to be adopted 14
1.10 Where else can one find out about cross over trials? 16
2 Some basic considerations concerning estimation
in clinical trials* 17
2.1 The purpose of this chapter 17
2.2 Assumed background knowledge 17
2.3 Control in clinical trials 26
2.4 Two purposes of estimation 28
2.5 Some features of estimation 28
2.6 Practical consequences for cross over trials 33
3 The AB/BA design with Normal data 35
3.1 An example 35
3.2 A simple analysis ignoring the effect of period 37
3.3 Student s approach* 41
3.4 Assumptions in the matched pairs t approach 42
3.5 Adjusting for a period effect: two sample t approach 46
3.6 Adjusting for a period effect: the Hills Armitage approach 47
3.7 Examining period effects 50
3.8 Testing for carry over and/or treatment by period interaction* 51
3.9 A model for the AB/BA cross over* 53
v
vi Contents
3.10 Carry over or treatment by period interaction?* 55
3.11 Confidence intervals for carry over* 56
3.12 Are unbiased estimators of the treatment effect available?* 57
3.13 Can we adjust for carry over?* 58
3.14 The two stage analysis* 58
3.15 Correcting the two stage procedure* 61
3.16 Use of baseline measurements 62
3.17 A Bayesian approach 68
3.18 Computer analysis 72
3.19 Further reading 81
3.20 Recommendations 82
Appendix 3.1 Analysis with GenStat® 83
Appendix 3.2 Analysis with S Plus® 85
4 Other outcomes and the AB/BA design 89
4.1 Introduction 89
4.2 Transformations 89
4.3 Non parametric methods 98
4.4 Binary outcomes 126
4.5 Ordered categorical data 135
4.6 Frequency data 139
4.7 Survival data* 143
4.8 Final remarks 148
Appendix 4.1 Analysis with GenStat® 148
Appendix 4.2 Analysis with S PIus® 153
5 Normal data from designs with three or more
treatments 157
5.1 Why do we have designs with three or more treatments? 157
5.2 Sequences for trials with three or more treatments 160
5.3 Analyses ignoring the effect of period 163
5.4 Allowing for period effects 170
5.5 Other miscellaneous issues 179
5.6 Recommendations 182
Appendix 5.1 Analysis with GenStat® 183
Appendix 5.2 Analysis with S Plus® 184
6 Other outcomes from designs with three or more
treatments 187
6.1 Introduction 187
6.2 Analyses which take no account of period effects 187
6.3 Non parametric analyses adjusting for period effects 188
6.4 Hodges Lehmann type estimators* 196
6.5 A stratified period adjusted sign test 196
6.6 Binary data 199
6.7 Other analyses 202
Appendix 6.1 Analysis with GenStat® 202
Appendix 6.2 Analysis with S Plus® 202
/toft..
Contents vii
7 Some special designs 205
7.1 The scope of this chapter 205
7.2 Factorial designs 205
7.3 Incomplete block designs 211
7.4 n of 1 trials 227
7.5 Bioequivalence studies 231
Appendix 7.1 Analysis with GenStat® 242
Appendix 7.2 Analysis with S Plus® 243
8 Graphical and tabular presentation of cross over
trials 245
8.1 Basic principles 245
8.2 Patient listings 246
8.3 Response by patient scatter plots 249
8.4 Treatment by treatment scatter plots 250
8.5 Treatment by treatment histograms 251
8.6 Basic estimator scatter plots 252
8.7 Effect plots 256
8.8 Treatment centred residual plots 258
9 Various design issues 261
9.1 Introduction 261
9.2 Parallel group or cross over? 263
9.3 Carry over and the length of the wash out period 271
9.4 Choosing sequences for a cross over 272
9.5 Sample size issues. 277
9.6 Drop outs, protocol violations and missing observations 286
Appendix 9.1 Planning trials with GenStat® 289
Appendix 9.2 Planning trials with S Plus® 292
10 Mathematical approaches to carry over* 295
10.1 The purpose of this chapter 295
10.2 An illustrative example 296
10.3 Five reasons for believing that the simple carry over model is not useful 298
10.4 In summary: the case against mathematical approaches to carry over 310
10.5 Using the simple carry over model 310
10.6 Where to find out more about the simple carry over model 322
References 323
Author index ^35
Subject index 339
|
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| discipline | Medizin |
| edition | 2. ed. |
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| language | English |
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| physical | XV, 345 S. graph. Darst. |
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| spelling | Senn, Stephen Verfasser aut Cross over trials in clinical research Stephen Senn Cross-over trials in clinical research 2. ed. Chichester [u.a.] Wiley 2002 XV, 345 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Statistics in practice Medisch onderzoek gtt Statistische methoden gtt Statistik Clinical Trials as Topic methods Cross-Over Studies Crossover trials Statistics as Topic Experiment (DE-588)4015999-1 gnd rswk-swf Kontrollierte klinische Studie (DE-588)4202997-1 gnd rswk-swf Biostatistik (DE-588)4729990-3 gnd rswk-swf Kontrollierte klinische Studie (DE-588)4202997-1 s DE-604 Biostatistik (DE-588)4729990-3 s Experiment (DE-588)4015999-1 s 1\p DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009942438&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Senn, Stephen Cross over trials in clinical research Medisch onderzoek gtt Statistische methoden gtt Statistik Clinical Trials as Topic methods Cross-Over Studies Crossover trials Statistics as Topic Experiment (DE-588)4015999-1 gnd Kontrollierte klinische Studie (DE-588)4202997-1 gnd Biostatistik (DE-588)4729990-3 gnd |
| subject_GND | (DE-588)4015999-1 (DE-588)4202997-1 (DE-588)4729990-3 |
| title | Cross over trials in clinical research |
| title_alt | Cross-over trials in clinical research |
| title_auth | Cross over trials in clinical research |
| title_exact_search | Cross over trials in clinical research |
| title_full | Cross over trials in clinical research Stephen Senn |
| title_fullStr | Cross over trials in clinical research Stephen Senn |
| title_full_unstemmed | Cross over trials in clinical research Stephen Senn |
| title_short | Cross over trials in clinical research |
| title_sort | cross over trials in clinical research |
| topic | Medisch onderzoek gtt Statistische methoden gtt Statistik Clinical Trials as Topic methods Cross-Over Studies Crossover trials Statistics as Topic Experiment (DE-588)4015999-1 gnd Kontrollierte klinische Studie (DE-588)4202997-1 gnd Biostatistik (DE-588)4729990-3 gnd |
| topic_facet | Medisch onderzoek Statistische methoden Statistik Clinical Trials as Topic methods Cross-Over Studies Crossover trials Statistics as Topic Experiment Kontrollierte klinische Studie Biostatistik |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009942438&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT sennstephen crossovertrialsinclinicalresearch |