Clinical trials in cancer: principles and practice
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Oxford
Univ. Press
2003
|
| Ausgabe: | 1. publ. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XVII, 367 S. graph. Darst. |
| ISBN: | 019262959X |
Internformat
MARC
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| 250 | |a 1. publ. | ||
| 264 | 1 | |a Oxford |b Univ. Press |c 2003 | |
| 300 | |a XVII, 367 S. |b graph. Darst. | ||
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| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Anticancéreux - Essais | |
| 650 | 4 | |a Cancer - Traitement - Évaluation | |
| 650 | 7 | |a Clinical trials |2 gtt | |
| 650 | 7 | |a Kanker |2 gtt | |
| 650 | 4 | |a Études cliniques | |
| 650 | 4 | |a Antineoplastic agents |x Testing | |
| 650 | 4 | |a Cancer |x Treatment |x Evaluation | |
| 650 | 4 | |a Clinical Trials as Topic |x methods | |
| 650 | 4 | |a Clinical trials | |
| 650 | 4 | |a Neoplasms |x therapy | |
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Datensatz im Suchindex
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|---|---|
| adam_text | Contents
1 Introduction 1
2 The public perspective 5
2.1 Introduction 5
2.2 Barriers to taking part in trials 6
2.3 Informed consent 8
2.3.1 Public opinion concerning consent 9
2.3.2 How much information should be disclosed? 10
2.3.3 Explaining randomization and rationale for
trials 10
2.3 A Patient information sheets 12
2.4 Informing participants about the results of trials 14
2.5 Involving the public in designing trials and
setting research agendas 15
2.5.1 NCI directors consumer liaison group 16
2.6 Education and raising public awareness of trials 18
2.7 Conclusions 20
References 21
3 What type of trial is needed? 25
3.1 Introduction 25
3.1.1 Phases of clinical trials 25
3.2 Phase I Clinical pharmacology and toxicity 26
3.3 Phase II Initial investigation of treatment activity 26
3.3.1 General aim 26
3.3.2 The importance of prospective conduct 27
3.3.3 Common phase II designs 27
3.3.4 Choice of design 30
3.3.5 Limitations of conventional phase II trials 30
3.4 Phase III Full scale comparative treatment
evaluation 31
3.4.1 The importance of randomization 32
3.4.2 Non randomized comparisons an
introduction 32
3.4.3 Historical controls 33
3.4.4 Concurrent controls 36
3.5 Phase IV Post marketing surveillance 37
I 3.6 Positioning your trial 37
3.7 Conclusion 42
References 42
4 Design issues for randomized trials 44
4.1 Introduction 44
4.2 Key design decisions 44
4.2.1 Choice of arms 44
4.2.2 Efficacy, equivalence or non inferiority? 46
4.2.3 Explanatory or pragmatic? 47
4.3 Timing of randomization and consent 53
4.3.1 Problems with the conventional order of
events 52
4.3.2 Alternative randomization procedures 53
4.4 Unit of randomization individuals or groups? 55
4.4.1 What are the advantages of cluster
randomization? 56
4.4.2 What are the disadvantages of cluster
randomization? 57
4.4.3 Further reading 57
4.5 Designs for randomized trials 58
4.5.1 Introduction 58
4.5.2 Parallel groups 58
4.5.3 Factorial designs 59
4.5.4 Cross over trials 63
4.6 Sequential randomizations within and between trials 64
4.7 Allocation methods for randomized trials 68
A.I A Introduction 68
4.7.2 Simple (pure) randomization 69
4.7.3 Block randomization (random permuted
blocks) 70
A.I .A Stratified randomization 71
4.7.5 Minimization 73
4.7.6 Sealed envelope randomization 76
4.7.7 Practical issues 76
4.8 Allocation concealment blinding/masking 77
4.8.1 Definitions 77
4.8.2 Placebos 78
4.8.3 Practicalities of using placebos or blinded
treatments 79
4.8.4 General guidance 79
4.9 Conclusion 80
References 80
5 Trial size 83
5.1 Introduction 83
5.2 Outcome measures 84
5.3 Basic considerations 86
5.3.1 What size of type I error is acceptable? 87
5.3.2 What size of type II error is acceptable? 89
5.3.3 What do you expect of the control arm? 90
5.3.4 What size of difference between treatments
is important? 91
5.3.5 Allocation ratios 99
5.4 Calculating sample sizes 100
5.4.1 Continuous data 101
5.4.2 Binary data 104
5.4.3 Survival data 104
5.4.4 Non compliers and drop outs 106
5.4.5 Phase II trials 106
5.5 The perfect and the practicable 109
5.6 Changing sample sizes mid trial 111
5.7 Sample size tables and software /12
5.8 Conclusions 114
References 114
6 Quality of life in clinical trials 116
6.1 Introduction 116
6.2 The rationale behind the assessment of QL in
randomized clinical trials in cancer 117
6.2.1 What is quality of life? 117
6.2.2 Why measure QL? 118
6.2.3 Who should assess quality of life? 119
6.2 A Conditions for patient completed
questionnaires 120
6.2.5 Response shift 121
6.3 Implementation of QL into trials 122
6.3.1 Which trials should include a QL
assessment? 122
6.3.2 The importance of setting hypotheses 124
6.3.3 Identifying key symptoms 125
6.3.4 Identifying key timepoints 127
6.3.5 How many patients are required? 128
6.4 Choosing the questionnaire 129
6.4.1 Single global question and psychometrics 130
6.4.2 Development of QL questionnaires 131
xiv | CONTENTS
8 Conducting trials 187
8.1 Introduction 187
8.2 What needs to be done? 187
8.3 Launching the trial and recruiting centres 188
8.4 Promoting and publicizing the trial 189
8.5 Day to day conduct of the trial and data
management 190
8.5.1 Obtaining, recording and checking data 190
8.5.2 Source data verification 190
8.5.3 Data entry checking 193
8.6 Maintaining good collaboration 194
8.6.1 Day to day contact between trial coordinators and
collaborating centres 194
8.6.2 Regular collaborators meetings 195
8.7 Conferring with patient advocacy groups 196
8.8 Conducting analyses 196
8.9 Preparing reports for presentation and publication 197
8.9.1 Style of authorship 197
8.9.2 Acknowledgements 198
8.9.3 Drafting reports 199
8.10 Independent data monitoring and supervision 199
8.10.1 Membership and functions of the data monitoring and
ethics committee 200
8.10.2 Membership and functions of the trial
steering committee 203
8.11 Computing and information technology 205
8.11.1 Communication 205
8.11.2 Randomization software 206
8.11.3 Clinical trials software 206
8.12 Data protection 207
8.12.1 Principles of data protection 208
8.12.2 Common sense rules for protecting data 209
8.12.3 Encrypting data 209
8.12.4 Worldwide availability of data 209
8.13 Research misconduct 210
8.13.1 Definition of misconduct 211
8.13.2 Examples 211
8.13.3 Detecting possible misconduct and
whistle blowing 211
8.13.4 Prevention 212
8.14 Conclusion 212
References 213
CONTENTS XV
9 Analysis 214
9.1 Introduction 214
9.2 Significance testing and estimation 215
9.2.1 Significance testing 215
9.2.2 Estimation 215
9.2.3 Differences and relationship between significance
testing and estimation 216
9.3 Statistical methods 217
9.3.1 Binary data 217
9.3.2 More than two categories 222
9.3.3 Continuous data 224
9.3.4 Time to event data 226
9.3.5 Longitudinal data (repeated measures) 235
9.4 Practical guidance in analyzing the data
from a randomized trial 235
9.4.1 Intention to treat analysis 235
9.4.2 Intention to treat analysis and equivalence
trials 238
9.4.3 Patient characteristics 239
9.4.4 Treatment and compliance 240
9.4.5 Response 241
9.4.6 Toxicity 244
9.4.7 Time to event 245
9.4.8 Subgroup analysis 248
9.4.9 Quality of life (including longitudinal) data 252
9.5 Interim analyses 263
9.6 Conclusion 269
References 269
10 Reporting and interpreting results 272
10.1 Introduction 272
10.2 General principles 272
10.3 Structure and content of a trial report CONSORT 272
10.3.1 The CONSORT guidelines justification 27}
10.3.2 Other points to include 279
10.4 Presenting results relative or absolute measures? 279
10.5 Practical issues in reporting 280
10.5.1 Always publish 280
10.5.2 When should the first results be published? 281
10.5.3 How often should trial results be updated for
publication? 281
10.5.4 Choosing an appropriate journal 282
10.5.5 The covering letter 282
10.5.6 Publishing data from sub studies 283
10.6 Disseminating results 284
10.6.1 Conference presentations 284
10.6.2 Press releases 285
10.6.3 Informing the trial patients and/or their
families 289
10.7 Interpreting trials 289
10.7.1 Is the result (or conclusion) falsely negative? 289
10.7.2 Is the result (or conclusion) falsely positive? 290
10.8 Conclusion 292
References 293
11 Systematic review and meta analysis 294
11.1 Introduction 294
11.1.1 Definitions 295
11.2 Why we need systematic reviews and meta analyses 295
11.2.1 Reducing the effect of random error 296
11.2.2 Reducing the effect of bias 297
11.2.3 Underlying assumptions of meta analysis 297
11.3 Different types of meta analysis 298
11.3.1 Comparing IPD and other approaches 298
11.3.2 Potential benefits of the IPD approach 300
11.3.3 Potential costs of the IPD approach 301
11.3.4 Choosing which approach is appropriate 301
11.4 Methodological principles of systematic review 302
11.4.1 Include only randomized trials 302
11.4.2 Include all randomized trials 303
11.4.3 Include trials once only 304
11.4.4 Include all and only randomized patients 305
11.5 Practical methods for systematic review and
meta analysis 306
11.5.1 Defining the question 307
11.5.2 Writing a protocol 308
11.5.3 Organizational structures 308
11.5.4 Identifying trials 310
11.5.5 Data collection 315
11.5.6 Data checking 319
11.5.7 Analyses 322
11.5.8 Reporting and disseminating results 331
11.6 Some statistical issues in meta analysis 333
11.6.1 Fixed versus random effect model 333
11.6.2 Heterogeneity 333
11.6.3 Meta regression 334
11.6.4 Investigating publication bias 334
11.7 Example of an IPD meta analysis: Postoperative radiotherapy
in non small cell lung cancer 336
11.8 The Cochrane collaboration 340
11.9 Conclusions 341
References 342
12 Benefits of an established trials centre and research group 346
12.1 Introduction 346
12.2 The characteristics of an established trials centre 346
12.3 International collaboration between trials centres 346
12.4 Coherent programmes of trials 348
12.4.1 Framing clinically relevant hypotheses 348
12.4.2 Example of a strategically planned programme
of clinical research 348
12.5 Maintaining a network of collaborating centres 349
12.5.1 Collaborators meetings 350
12.5.2 Planning group meetings 351
12.5.3 Newsletters and annual reports 351
12.6 Trials centre staff 351
12.6.1 Staff and expertise 351
12.6.2 Standard operating procedures 352
12.7 Links with patient advocacy groups 352
12.8 Long term follow up, ownership and retention
of data 353
12.9 Methodological and trials associated research 354
12.10 Conclusion 356
References 356
Index 359
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| spelling | Clinical trials in cancer principles and practice David J. Girling ... 1. publ. Oxford Univ. Press 2003 XVII, 367 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Anticancéreux - Essais Cancer - Traitement - Évaluation Clinical trials gtt Kanker gtt Études cliniques Antineoplastic agents Testing Cancer Treatment Evaluation Clinical Trials as Topic methods Clinical trials Neoplasms therapy Krebs Medizin (DE-588)4073781-0 gnd rswk-swf Kontrollierte klinische Studie (DE-588)4202997-1 gnd rswk-swf Krebs Medizin (DE-588)4073781-0 s Kontrollierte klinische Studie (DE-588)4202997-1 s DE-604 Girling, David J. Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010049355&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Clinical trials in cancer principles and practice Anticancéreux - Essais Cancer - Traitement - Évaluation Clinical trials gtt Kanker gtt Études cliniques Antineoplastic agents Testing Cancer Treatment Evaluation Clinical Trials as Topic methods Clinical trials Neoplasms therapy Krebs Medizin (DE-588)4073781-0 gnd Kontrollierte klinische Studie (DE-588)4202997-1 gnd |
| subject_GND | (DE-588)4073781-0 (DE-588)4202997-1 |
| title | Clinical trials in cancer principles and practice |
| title_auth | Clinical trials in cancer principles and practice |
| title_exact_search | Clinical trials in cancer principles and practice |
| title_full | Clinical trials in cancer principles and practice David J. Girling ... |
| title_fullStr | Clinical trials in cancer principles and practice David J. Girling ... |
| title_full_unstemmed | Clinical trials in cancer principles and practice David J. Girling ... |
| title_short | Clinical trials in cancer |
| title_sort | clinical trials in cancer principles and practice |
| title_sub | principles and practice |
| topic | Anticancéreux - Essais Cancer - Traitement - Évaluation Clinical trials gtt Kanker gtt Études cliniques Antineoplastic agents Testing Cancer Treatment Evaluation Clinical Trials as Topic methods Clinical trials Neoplasms therapy Krebs Medizin (DE-588)4073781-0 gnd Kontrollierte klinische Studie (DE-588)4202997-1 gnd |
| topic_facet | Anticancéreux - Essais Cancer - Traitement - Évaluation Clinical trials Kanker Études cliniques Antineoplastic agents Testing Cancer Treatment Evaluation Clinical Trials as Topic methods Neoplasms therapy Krebs Medizin Kontrollierte klinische Studie |
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