Statistical aspects of the design and analysis of clinical trials:
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| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
London
Imperial College Press
2004
|
| Edition: | Rev. ed. |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XIII, 323 S. graph. Darst. |
| ISBN: | 1860944418 |
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| 245 | 1 | 0 | |a Statistical aspects of the design and analysis of clinical trials |c Brian S. Everitt ; Andrew Pickles |
| 250 | |a Rev. ed. | ||
| 264 | 1 | |a London |b Imperial College Press |c 2004 | |
| 300 | |a XIII, 323 S. |b graph. Darst. | ||
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Record in the Search Index
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| adam_text | Contents
PREFACE v
CHAPTER 1. An Introduction to Clinical Trials 1
1.1 INTRODUCTION 1
1.2 A BRIEF HISTORY OF CLINICAL TRIALS 2
1.3 TYPES OF CLINICAL TRIAL 5
1.4 ETHICS OF CLINICAL TRIALS 9
1.5 CLINICAL TRIAL PROTOCOLS 16
1.6 SUMMARY 17
CHAPTER 2. Treatment Allocation, the Size of
Trials and Reporting Results 18
2.1 INTRODUCTION 18
2.2 TREATMENT ASSIGNMENT METHODS 18
2.2.1 Simple Randomisation 21
2.2.2 Blocked Randomisation 22
2.2.3 Stratified Randomisation 24
2.2.4 Minimisation Method 26
2.2.5 Unequal Randomisation 27
2.3 THE SIZE OF A CLINICAL TRIAL 29
2.4 REPORTING RESULTS 33
2.5 SUMMARY 35
vii
viii Contents
CHAPTER 3. Monitoring Trial Progress: Outcome
Measures, Compliance, Dropouts and
Interim Analyses 37
3.1 INTRODUCTION 37
3.2 OUTCOME MEASURES 38
3.3 COMPLIANCE, DROPOUTS AND
INTENTION TO TREAT 41
3.3.1 Intention to Treat 45
3.3.2 A Taxonomy of Dropouts 51
3.4 INTERIM ANALYSES IN CLINICAL TRIALS 55
3.4.1 Group Sequential Procedures — Bayesian Perspec¬
tive 64
3.5 SUMMARY 67
CHAPTER 4. Basic Analyses of Clinical Trials, the
Generalised Linear Model and the
Economic Evaluation of Trials 69
4.1 INTRODUCTION 69
4.2 A BRIEF REVIEW OF BASIC STATISTICS 70
4.3 GENERALISED LINEAR MODELS 77
4.3.1 Models for Counts: the Treatment of Familial
Adenomatous Polyposis (FAP) with a
Non Steroidal Anti Inflammatory Drug 82
4.3.2 Ordinal Response Models: A Clinical Trial
in Lymphoma 88
4.3.2.1 Models with parallel linear predictors 88
4.3.2.2 Non parallel models 89
4.3.2.3 Model estimation 90
4.4 MULTIPLE ENDPOINTS 92
4.5 ECONOMIC EVALUATION OF TRIALS 96
4.5.1 Measuring Costs 96
4.5.2 Analysis of Cost Data 98
4.5.3 Cost Benefit Analysis 100
Contents ix
4.5.4 An Example: Cognitive Behavioral Therapy .... 101
4.6 SUMMARY 105
CHAPTER 5. Simple Approaches to the Analysis of
Longitudinal Data from Clinical Trials 107
5.1 INTRODUCTION 107
5.2 GRAPHICAL METHODS FOR DISPLAYING
LONGITUDINAL DATA 108
5.3 TIME BY TIME ANALYSIS OF
LONGITUDINAL DATA 117
5.4 RESPONSE FEATURE ANALYSIS OF
LONGITUDINAL DATA 119
5.4.1 Choosing Summary Measures 120
5.4.2 Incorporating Pre Randomisation, Baseline
Measures into the Response Feature Approach . . 128
5.4.3 Response Feature Analysis when the Response
Variable is Binary 132
5.5 SUMMARY 139
CHAPTER 6. Multivariate Normal Regression
Models for Longitudinal Data from
Clinical Trials 141
6.1 INTRODUCTION 141
6.2 SOME GENERAL COMMENTS ABOUT MODELS
FOR LONGITUDINAL DATA 143
6.3 MISSING VALUES AND LIKELIHOOD BASED
INFERENCE FOR LONGITUDINAL DATA 145
6.4 MAXIMUM LIKELIHOOD ESTIMATION ASSUMING
NORMALITY 147
6.5 NUMERICAL EXAMPLES 149
6.5.1 Oestrogen Patches in the Treatment of Post Natal
Depression 149
6.5.2 Post Surgical Recovery in Young Children 156
x Contents
6.6 ANOVA AND MANOVA APPROACHES TO THE
ANALYSIS OF LONGITUDINAL DATA 164
6.7 INFORMATIVE DROP OUTS 165
6.8 OTHER METHODS FOR THE ANALYSIS OF
LONGITUDINAL DATA 170
6.9 SUMMARY 173
CHAPTER 7. Models for Non Normal Longitudinal
Data from Clinical Trials 175
7.1 INTRODUCTION 175
7.2 MARGINAL MODELS 176
7.2.1 Marginal Modelling using Generalised
Estimating Equations 179
7.3 RANDOM EFFECTS MODELS 189
7.4 TRANSITION MODELS 193
7.5 A COMPARISON OF METHODS 196
7.6 MISSING DATA AND WEIGHTED ESTIMATING
EQUATIONS 198
7.6.1 Missing Data in a Longitudinal Clinical Trial
with an Ordinal Response 199
7.7 SUMMARY 202
CHAPTER 8. Survival Analysis 203
8.1 INTRODUCTION 203
8.2 THE SURVIVOR FUNCTION AND THE HAZARD
FUNCTION 204
8.2.1 Survivor Function 204
8.2.2 The Hazard Function 211
8.3 REGRESSION MODELS FOR SURVIVAL DATA ... 215
8.4 ACCELERATED FAILURE TIME MODELS 216
8.5 PROPORTIONAL HAZARDS MODEL 220
8.5.1 Proportional Hazards 220
xii Contents
9.4.3 Prior Distributions as a Numerical Device 258
9.4.4 Alternative Models and Model Selection 258
9.5 A NUMERICAL EXAMPLE OF USING BAYESIAN
ESTIMATION 259
9.6 INFORMATIVE PRIORS 262
9.7 PRIORS AND STOPPING RULES FOR TRIAL
MONITORING 263
9.7.1 Clinical Demands 264
9.7.2 Clinical Beliefs 266
9.8 MONITORING 267
9.8.1 The Prior as a Handicap 267
9.8.2 Recognising Heterogeneity in Priors:
Enthusiasts and Sceptics 268
9.9 SAMPLE SIZE ESTIMATION FOR EARLY
PHASE TRIALS 270
9.10 REPORTING OF RESULTS 273
9.11 SUMMARY 273
CHAPTER 10. Meta Analysis 275
10.1 INTRODUCTION 275
10.2 SELECTION OF STUDIES — WHAT TO INCLUDE 277
10.3 THE STATISTICS OF META ANALYSIS 282
10.4 TWO EXAMPLES OF THE APPLICATION
OF META ANALYSIS 290
10.4.1 The Comparison of Sodium Monofluorophosphate
(SMFP) and Sodium Fluoride (NaF) Toothpastes
in the Prevention of Caries Development 290
10.4.2 The Effectiveness of Aspirin in Preventing Death
after a Myocardial Infarction 291
10.5 BAYESIAN META ANALYSIS 293
10.6 META ANALYSIS IN MORE COMPLEX SETTINGS 295
10.7 SUMMARY 295
Contents xiii
APPENDIX A. Software 298
REFERENCES 303
INDEX 320
|
| adam_txt |
Contents
PREFACE v
CHAPTER 1. An Introduction to Clinical Trials 1
1.1 INTRODUCTION 1
1.2 A BRIEF HISTORY OF CLINICAL TRIALS 2
1.3 TYPES OF CLINICAL TRIAL 5
1.4 ETHICS OF CLINICAL TRIALS 9
1.5 CLINICAL TRIAL PROTOCOLS 16
1.6 SUMMARY 17
CHAPTER 2. Treatment Allocation, the Size of
Trials and Reporting Results 18
2.1 INTRODUCTION 18
2.2 TREATMENT ASSIGNMENT METHODS 18
2.2.1 Simple Randomisation 21
2.2.2 Blocked Randomisation 22
2.2.3 Stratified Randomisation 24
2.2.4 Minimisation Method 26
2.2.5 Unequal Randomisation 27
2.3 THE SIZE OF A CLINICAL TRIAL 29
2.4 REPORTING RESULTS 33
2.5 SUMMARY 35
vii
viii Contents
CHAPTER 3. Monitoring Trial Progress: Outcome
Measures, Compliance, Dropouts and
Interim Analyses 37
3.1 INTRODUCTION 37
3.2 OUTCOME MEASURES 38
3.3 COMPLIANCE, DROPOUTS AND
INTENTION TO TREAT 41
3.3.1 Intention to Treat 45
3.3.2 A Taxonomy of Dropouts 51
3.4 INTERIM ANALYSES IN CLINICAL TRIALS 55
3.4.1 Group Sequential Procedures — Bayesian Perspec¬
tive 64
3.5 SUMMARY 67
CHAPTER 4. Basic Analyses of Clinical Trials, the
Generalised Linear Model and the
Economic Evaluation of Trials 69
4.1 INTRODUCTION 69
4.2 A BRIEF REVIEW OF BASIC STATISTICS 70
4.3 GENERALISED LINEAR MODELS 77
4.3.1 Models for Counts: the Treatment of Familial
Adenomatous Polyposis (FAP) with a
Non Steroidal Anti Inflammatory Drug 82
4.3.2 Ordinal Response Models: A Clinical Trial
in Lymphoma 88
4.3.2.1 Models with parallel linear predictors 88
4.3.2.2 Non parallel models 89
4.3.2.3 Model estimation 90
4.4 MULTIPLE ENDPOINTS 92
4.5 ECONOMIC EVALUATION OF TRIALS 96
4.5.1 Measuring Costs 96
4.5.2 Analysis of Cost Data 98
4.5.3 Cost Benefit Analysis 100
Contents ix
4.5.4 An Example: Cognitive Behavioral Therapy . 101
4.6 SUMMARY 105
CHAPTER 5. Simple Approaches to the Analysis of
Longitudinal Data from Clinical Trials 107
5.1 INTRODUCTION 107
5.2 GRAPHICAL METHODS FOR DISPLAYING
LONGITUDINAL DATA 108
5.3 TIME BY TIME ANALYSIS OF
LONGITUDINAL DATA 117
5.4 RESPONSE FEATURE ANALYSIS OF
LONGITUDINAL DATA 119
5.4.1 Choosing Summary Measures 120
5.4.2 Incorporating Pre Randomisation, Baseline
Measures into the Response Feature Approach . . 128
5.4.3 Response Feature Analysis when the Response
Variable is Binary 132
5.5 SUMMARY 139
CHAPTER 6. Multivariate Normal Regression
Models for Longitudinal Data from
Clinical Trials 141
6.1 INTRODUCTION 141
6.2 SOME GENERAL COMMENTS ABOUT MODELS
FOR LONGITUDINAL DATA 143
6.3 MISSING VALUES AND LIKELIHOOD BASED
INFERENCE FOR LONGITUDINAL DATA 145
6.4 MAXIMUM LIKELIHOOD ESTIMATION ASSUMING
NORMALITY 147
6.5 NUMERICAL EXAMPLES 149
6.5.1 Oestrogen Patches in the Treatment of Post Natal
Depression 149
6.5.2 Post Surgical Recovery in Young Children 156
x Contents
6.6 ANOVA AND MANOVA APPROACHES TO THE
ANALYSIS OF LONGITUDINAL DATA 164
6.7 INFORMATIVE DROP OUTS 165
6.8 OTHER METHODS FOR THE ANALYSIS OF
LONGITUDINAL DATA 170
6.9 SUMMARY 173
CHAPTER 7. Models for Non Normal Longitudinal
Data from Clinical Trials 175
7.1 INTRODUCTION 175
7.2 MARGINAL MODELS 176
7.2.1 Marginal Modelling using Generalised
Estimating Equations 179
7.3 RANDOM EFFECTS MODELS 189
7.4 TRANSITION MODELS 193
7.5 A COMPARISON OF METHODS 196
7.6 MISSING DATA AND WEIGHTED ESTIMATING
EQUATIONS 198
7.6.1 Missing Data in a Longitudinal Clinical Trial
with an Ordinal Response 199
7.7 SUMMARY 202
CHAPTER 8. Survival Analysis 203
8.1 INTRODUCTION 203
8.2 THE SURVIVOR FUNCTION AND THE HAZARD
FUNCTION 204
8.2.1 Survivor Function 204
8.2.2 The Hazard Function 211
8.3 REGRESSION MODELS FOR SURVIVAL DATA . 215
8.4 ACCELERATED FAILURE TIME MODELS 216
8.5 PROPORTIONAL HAZARDS MODEL 220
8.5.1 Proportional Hazards 220
xii Contents
9.4.3 Prior Distributions as a Numerical Device 258
9.4.4 Alternative Models and Model Selection 258
9.5 A NUMERICAL EXAMPLE OF USING BAYESIAN
ESTIMATION 259
9.6 INFORMATIVE PRIORS 262
9.7 PRIORS AND STOPPING RULES FOR TRIAL
MONITORING 263
9.7.1 Clinical Demands 264
9.7.2 Clinical Beliefs 266
9.8 MONITORING 267
9.8.1 The Prior as a Handicap 267
9.8.2 Recognising Heterogeneity in Priors:
Enthusiasts and Sceptics 268
9.9 SAMPLE SIZE ESTIMATION FOR EARLY
PHASE TRIALS 270
9.10 REPORTING OF RESULTS 273
9.11 SUMMARY 273
CHAPTER 10. Meta Analysis 275
10.1 INTRODUCTION 275
10.2 SELECTION OF STUDIES — WHAT TO INCLUDE 277
10.3 THE STATISTICS OF META ANALYSIS 282
10.4 TWO EXAMPLES OF THE APPLICATION
OF META ANALYSIS 290
10.4.1 The Comparison of Sodium Monofluorophosphate
(SMFP) and Sodium Fluoride (NaF) Toothpastes
in the Prevention of Caries Development 290
10.4.2 The Effectiveness of Aspirin in Preventing Death
after a Myocardial Infarction 291
10.5 BAYESIAN META ANALYSIS 293
10.6 META ANALYSIS IN MORE COMPLEX SETTINGS 295
10.7 SUMMARY 295
Contents xiii
APPENDIX A. Software 298
REFERENCES 303
INDEX 320 |
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| spelling | Everitt, Brian 1944- Verfasser (DE-588)121459411 aut Statistical aspects of the design and analysis of clinical trials Brian S. Everitt ; Andrew Pickles Rev. ed. London Imperial College Press 2004 XIII, 323 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Statistics methods Clinical Trials Research Design Data Interpretation, Statistical Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic Clinical trials Statistical methods Statistics as Topic methods Pickles, Andrew Verfasser aut HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015467074&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Everitt, Brian 1944- Pickles, Andrew Statistical aspects of the design and analysis of clinical trials Statistics methods Clinical Trials Research Design Data Interpretation, Statistical Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic Clinical trials Statistical methods Statistics as Topic methods |
| title | Statistical aspects of the design and analysis of clinical trials |
| title_auth | Statistical aspects of the design and analysis of clinical trials |
| title_exact_search | Statistical aspects of the design and analysis of clinical trials |
| title_exact_search_txtP | Statistical aspects of the design and analysis of clinical trials |
| title_full | Statistical aspects of the design and analysis of clinical trials Brian S. Everitt ; Andrew Pickles |
| title_fullStr | Statistical aspects of the design and analysis of clinical trials Brian S. Everitt ; Andrew Pickles |
| title_full_unstemmed | Statistical aspects of the design and analysis of clinical trials Brian S. Everitt ; Andrew Pickles |
| title_short | Statistical aspects of the design and analysis of clinical trials |
| title_sort | statistical aspects of the design and analysis of clinical trials |
| topic | Statistics methods Clinical Trials Research Design Data Interpretation, Statistical Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic Clinical trials Statistical methods Statistics as Topic methods |
| topic_facet | Statistics methods Clinical Trials Research Design Data Interpretation, Statistical Études cliniques - Méthodes statistiques Statistik Clinical Trials as Topic Clinical trials Statistical methods Statistics as Topic methods |
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