Design and Analysis of Clinical Trials
Concepts and Methodologies
(Sprache: Englisch)
Praise for the Second Edition:
"...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." --Journal of Clinical Research Best Practices
The...
"...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." --Journal of Clinical Research Best Practices
The...
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Klappentext zu „Design and Analysis of Clinical Trials “
Praise for the Second Edition:"...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." --Journal of Clinical Research Best Practices
The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include:
* New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine
* A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies
* Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts
* New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation
* A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines
* An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development
Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory
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scientists/researchers, statisticians, and graduate-level students.
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Inhaltsverzeichnis zu „Design and Analysis of Clinical Trials “
Preface xiPART I PRELIMINARIES
1 Introduction 3
1.1 What are Clinical Trials?, 3
1.2 History of Clinical Trials, 4
1.3 Regulatory Process and Requirements, 10
1.4 Investigational New Drug Application, 17
1.5 New Drug Application, 24
1.6 Clinical Development and Practice, 31
1.7 AIMS and Structure of the Book, 42
2 Basic Statistical Concepts 45
2.1 Introduction, 45
2.2 Uncertainty and Probability, 46
2.3 Bias and Variability, 49
2.4 Confounding and Interaction, 57
2.5 Descriptive and Inferential Statistics, 66
2.6 Hypotheses Testing and p-Values, 68
2.7 Clinical Significance and Clinical Equivalence, 75
2.8 Reproducibility and Generalizability, 79
3 Basic Design Considerations 85
3.1 Introduction, 85
3.2 Goals of Clinical Trials, 86
3.3 Target Population and Patient Selection, 90
3.4 Selection of Controls, 97
3.5 Statistical Considerations, 105
3.6 Other Issues, 112
3.7 Discussion, 115
4 Randomization and Blinding 117
4.1 Introduction, 117
4.2 Randomization Models, 118
4.3 Randomization Methods, 124
4.4 Implementation of Randomization, 144
4.5 Generalization of Controlled Randomized Trials, 149
4.6 Blinding, 153
4.7 Discussion, 160
PART II DESIGNS AND THEIR CLASSIFICATIONS
5 Designs for Clinical Trials 165
5.1 Introduction, 165
5.2 Parallel Group Designs, 167
5.3 Clustered Randomized Designs, 172
5.4 Crossover Designs, 177
5.5 Titration Designs, 185
5.6 Enrichment Designs, 191
5.7 Group Sequential Designs, 195
5.8 Placebo-Challenging Designs, 197
5.9 Blinded Reader Designs, 203
5.10 Discussion, 207
6 Designs for Cancer Clinical Trials 211
6.1
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Introduction, 211
6.2 General Considerations for Phase I Cancer Clinical Trials, 213
6.3 Single-Stage Up-and-Down Phase I Designs, 214
6.4 Two-Stage Up-and-Down Phase I Designs, 217
6.5 Continual Reassessment Method Phase I Designs, 219
6.6 Optimal and Flexible Multiple-Stage Designs, 222
6.7 Randomized Phase II Designs, 229
6.8 Discussion, 232
7 Classification of Clinical Trials 237
7.1 Introduction, 237
7.2 Multicenter Trials, 238
7.3 Superiority Trials, 245
7.4 Active Control and Equivalence/Noninferiority Trials, 248
7.5 Dose-Response Trials, 261
7.6 Combination Trials, 266
7.7 Bridging Studies and Global Trials, 278
7.8 Vaccine Clinical Trials, 285
7.9 QT Studies, 291
7.10 Discussion, 299
PART III ANALYSIS OF CLINICAL DATA
8 Analysis of Continuous Data 305
8.1 Introduction, 305
8.2 Estimation, 306
8.3 Test Statistics, 310
8.4 Analysis of Variance, 316
8.5 Analysis of Covariance, 323
8.6 Nonparametric Methods, 325
8.7 Repeated Measures, 332
8.8 Discussion, 341
9 Analysis of Categorical Data 343
9.1 Introduction, 343
9.2 Statistical Inference for One Sample, 345
9.3 Inference of Independent Samples, 358
9.4 Ordered Categorical Data, 364
9.5 Combining Categorical Data, 368
9.6 Model-Based Methods, 374
9.7 Repeated Categorical Data, 382
9.8 Discussion, 387
10 Censored Data and Interim Analys
6.2 General Considerations for Phase I Cancer Clinical Trials, 213
6.3 Single-Stage Up-and-Down Phase I Designs, 214
6.4 Two-Stage Up-and-Down Phase I Designs, 217
6.5 Continual Reassessment Method Phase I Designs, 219
6.6 Optimal and Flexible Multiple-Stage Designs, 222
6.7 Randomized Phase II Designs, 229
6.8 Discussion, 232
7 Classification of Clinical Trials 237
7.1 Introduction, 237
7.2 Multicenter Trials, 238
7.3 Superiority Trials, 245
7.4 Active Control and Equivalence/Noninferiority Trials, 248
7.5 Dose-Response Trials, 261
7.6 Combination Trials, 266
7.7 Bridging Studies and Global Trials, 278
7.8 Vaccine Clinical Trials, 285
7.9 QT Studies, 291
7.10 Discussion, 299
PART III ANALYSIS OF CLINICAL DATA
8 Analysis of Continuous Data 305
8.1 Introduction, 305
8.2 Estimation, 306
8.3 Test Statistics, 310
8.4 Analysis of Variance, 316
8.5 Analysis of Covariance, 323
8.6 Nonparametric Methods, 325
8.7 Repeated Measures, 332
8.8 Discussion, 341
9 Analysis of Categorical Data 343
9.1 Introduction, 343
9.2 Statistical Inference for One Sample, 345
9.3 Inference of Independent Samples, 358
9.4 Ordered Categorical Data, 364
9.5 Combining Categorical Data, 368
9.6 Model-Based Methods, 374
9.7 Repeated Categorical Data, 382
9.8 Discussion, 387
10 Censored Data and Interim Analys
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Autoren-Porträt von Shein-Chung Chow, Jen-pei Liu
SHEIN-CHUNG CHOW, PhD, is Professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine.JEN-PEI LIU, PhD, is Professor in the Department of Agronomy and Institute of Epidemiology and Preventive Medicine at the National Taiwan University. He has authored multiple articles and books on clinical trials and been involved in clinical trials as a biostatistician for more than twenty-five years.
Bibliographische Angaben
- Autoren: Shein-Chung Chow , Jen-pei Liu
- 2014, 3. Aufl., 892 Seiten, mit Abbildungen, Maße: 18,3 x 26 cm, Gebunden, Englisch
- Verlag: Wiley & Sons
- ISBN-10: 0470887656
- ISBN-13: 9780470887653
- Erscheinungsdatum: 25.10.2013
Sprache:
Englisch
Pressezitat
"In summary, this third edition is an impressive expansion beyond a remarkable second edition. This book would be good reference for biostatisticians, clinical researchers, and pharmaceutical scientists in clinical research and development." ( Journal of Biopharmaceutical Statistics , 1 July 2014)Kommentar zu "Design and Analysis of Clinical Trials"
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