Design and analysis of clinical trials: concepts and methodologies
Gespeichert in:
| Beteilige Person: | |
|---|---|
| Format: | Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
Hoboken, NJ
Wiley
2004
|
| Ausgabe: | 2. ed. |
| Schriftenreihe: | Wiley series in probability and statistics
|
| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013083305&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | XIII, 729 S. Ill. |
| ISBN: | 0471249858 |
Internformat
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Datensatz im Suchindex
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|---|---|
| adam_text | CONTENTS
Preface jx
Preface to the First Edition xi
1. Introduction 1
1.1 What are Clinical Trials?, 1
1.2 History of Clinical Trials, 3
1.3 Regulatory Process and Requirements, 7
1.4 Investigational New Drug Application, 15
1.5 New Drug Application, 22
1.6 Clinical Development and Practice, 31
1.7 Aims and Structure of the Book, 35
2. Basic Statistical Concepts 43
2.1 Introduction, 43
2.2 Uncertainty and Probability, 44
2.3 Bias and Variability, 47
2.4 Confounding and Interaction, 55
2.5 Descriptive and Inferential Statistics, 65
2.6 Hypothesis Testing and/? Values, 71
2.7 Clinical Significance and Clinical Equivalence, 77
2.8 Reproducibility and Generalizability, 82
3. Basic Design Considerations 88
3.1 Introduction, 88
3.2 Goals of Clinical Trials, 89
v
vi CONTENTS
3.3 Target Population and Patient Selection, 93
3.4 Selection of Controls, 100
3.5 Statistical Considerations, 109
3.6 Other Issues, 116
3.7 Discussion, 118
4. Randomization and Blinding 120
4.1 Introduction, 120
4.2 Randomization Models, 122
4.3 Randomization Methods, 127
4.4 Implementation of Randomization, 149
4.5 Generalization of Controlled Randomized Trials, 154
4.6 Blinding, 158
4.7 Discussion, 165
5. Designs for Clinical Trials 167
5.1 Introduction, 167
5.2 Parallel Group Designs, 169
5.3 Cluster Randomized Designs, 174
5.4 Crossover Designs, 179
5.5 Titration Designs, 188
5.6 Enrichment Designs, 194
5.7 Group Sequential Designs, 200
5.8 Placebo Challenging Design, 202
5.9 Blinded Reader Designs, 208
5.10 Discussion, 212
6. Designs for Cancer Clinical Trials 215
6.1 Introduction, 215
6.2 General Considerations for Phase I Cancer Clinical Trials, 217
6.3 Single Stage Up and Down Phase I Designs, 218
6.4 Two Stage Up and Down Phase I Designs, 220
6.5 Continual Reassessment Method Phase I Designs, 223
6.6 Optimal/Flexible Multiple Stage Designs, 226
6.7 Randomized Phase II Designs, 232
6.8 Discussion, 236
7. Classification of Clinical Trials 239
7.1 Introduction, 239
7.2 Multicenter Trial, 240
7.3 Superiority Trials, 247
7.4 Active Control and Equivalence/Noninferiority Trials, 250
7.5 Dose Response Trials, 265
7.6 Combination Trials, 270
7.7 Bridging Studies, 283
7.8 Vaccine Clinical Trials, 289
7.9 Discussion, 296
CONTENTS vii
8. Analysis of Continuous Data 300
8.1 Introduction, 300
8.2 Estimation, 301
8.3 Test Statistics, 305
8.4 Analysis of Variance, 311
8.5 Analysis of Covariance, 316
8.6 Nonparametrics, 320
8.7 Repeated Measures, 326
8.8 Discussion, 337
9. Analysis of Categorical Data 339
9.1 Introduction, 339
9.2 Statistical Inference for One Sample, 344
9.3 Inference of Independent Samples, 356
9.4 Ordered Categorical Data, 362
9.5 Combining Categorical Data, 366
9.6 Model Based Methods, 372
9.7 Repeated Categorical Data, 379
9.8 Discussion, 384
10. Censored Data and Interim Analysis 386
10.1 Introduction, 386
10.2 Estimation of the Survival Function, 388
10.3 Comparison between Survival Functions, 394
10.4 Cox s Proportional Hazard Model, 402
10.5 Calendar Time and Information Time, 417
10.6 Group Sequential Methods, 422
10.7 Discussion, 435
11. Sample Size Determination 438
11.1 Introduction, 438
11.2 Basic Concept, 439
11.3 Two Samples, 443
11.4 Multiple Samples, 452
11.5 Censored Data, 464
11.6 Dose Response Studies, 468
11.7 Crossover Designs, 474
11.8 Equivalence and Noninferiority Trials, 481
11.9 Multiple Stage Design in Cancer Trials, 492
11.10 Comparing Variabilities, 493
11.11 Discussion, 508
12. Issues in Efficacy Evaluation 510
12.1 Introduction, 510
12.2 Baseline Comparison, 512
viii CONTENTS
12.3 Intention to Treat Principle and Efficacy Analysis, 517
12.4 Adjustment for Covariates, 523
12.5 Multicenter Trials, 529
12.6 Multiplicity, 537
12.7 Data Monitoring, 546
12.8 Use of Genetic Information for Evaluation of Efficacy, 552
12.9 Sample Size Re estimation, 558
12.10 Discussion, 560
13. Safety Assessment 562
13.1 Introduction, 562
13.2 Extent of Exposure, 564
13.3 Coding of Adverse Events, 569
13.4 Analysis of Adverse Events, 584
13.5 Analysis of Laboratory Data, 591
13.6 Discussion, 600
14. Preparation and Implementation of a Clinical Protocol 602
14.1 Introduction, 602
14.2 Structure and Components of a Protocol, 603
14.3 Points to Be Considered and Common Pitfalls during
Development and Preparation of a Procotol, 609
14.4 Common Departures for Implementation of a Protocol, 612
14.5 Monitoring, Audit, and Inspection, 617
14.6 Quality Assessment of a Clinical Trial, 620
14.7 Discussion, 626
15. Clinical Data Management 628
15.1 Introduction, 628
15.2 Regulatory Requirements, 630
15.3 Development of Case Report Forms, 633
15.4 Database Development, 636
15.5 Data Entry, Query, and Correction, 638
15.6 Data Validation and Quality, 641
15.7 Database Lock, Archive, and Transfer, 642
15.8 Discussion, 645
Bibliography 649
Appendices 683
Index 713
|
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| discipline | Medizin |
| edition | 2. ed. |
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| id | DE-604.BV019756858 |
| illustrated | Illustrated |
| indexdate | 2024-12-20T12:05:11Z |
| institution | BVB |
| isbn | 0471249858 |
| language | English |
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| physical | XIII, 729 S. Ill. |
| publishDate | 2004 |
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| publisher | Wiley |
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| series2 | Wiley series in probability and statistics |
| spellingShingle | Chow, Shein-Chung Design and analysis of clinical trials concepts and methodologies Clinical trials Methodology Clinical trials Statistical methods Kontrollierte klinische Studie (DE-588)4202997-1 gnd Anwendung (DE-588)4196864-5 gnd Klinisches Experiment (DE-588)4164223-5 gnd Statistik (DE-588)4056995-0 gnd |
| subject_GND | (DE-588)4202997-1 (DE-588)4196864-5 (DE-588)4164223-5 (DE-588)4056995-0 |
| title | Design and analysis of clinical trials concepts and methodologies |
| title_auth | Design and analysis of clinical trials concepts and methodologies |
| title_exact_search | Design and analysis of clinical trials concepts and methodologies |
| title_full | Design and analysis of clinical trials concepts and methodologies Shein-Chung Chow ; Jen-Pei Liu |
| title_fullStr | Design and analysis of clinical trials concepts and methodologies Shein-Chung Chow ; Jen-Pei Liu |
| title_full_unstemmed | Design and analysis of clinical trials concepts and methodologies Shein-Chung Chow ; Jen-Pei Liu |
| title_short | Design and analysis of clinical trials |
| title_sort | design and analysis of clinical trials concepts and methodologies |
| title_sub | concepts and methodologies |
| topic | Clinical trials Methodology Clinical trials Statistical methods Kontrollierte klinische Studie (DE-588)4202997-1 gnd Anwendung (DE-588)4196864-5 gnd Klinisches Experiment (DE-588)4164223-5 gnd Statistik (DE-588)4056995-0 gnd |
| topic_facet | Clinical trials Methodology Clinical trials Statistical methods Kontrollierte klinische Studie Anwendung Klinisches Experiment Statistik |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013083305&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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