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Rosenberger / Lachin

Randomization in Clinical Trials

Theory and Practice

Medium: Buch
ISBN: 978-1-118-74224-2
Verlag: Wiley
Erscheinungstermin: 23.11.2015
Lieferfrist: bis zu 10 Tage

Praise for the First Edition

“All medical statisticians involved in clinical trials should read this book…”

- Controlled Clinical Trials

Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians.

Randomization in Clinical Trials: Theory and Practice, Second Edition features:

- Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials
- A new chapter on covariate-adaptive randomization, including minimization techniques and inference
- New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests
- Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding

Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics.

William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley.

John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.


Produkteigenschaften


  • Artikelnummer: 9781118742242
  • Medium: Buch
  • ISBN: 978-1-118-74224-2
  • Verlag: Wiley
  • Erscheinungstermin: 23.11.2015
  • Sprache(n): Englisch
  • Auflage: 2. Auflage 2015
  • Serie: Wiley Series in Probability and Statistics
  • Produktform: Gebunden
  • Gewicht: 529 g
  • Seiten: 288
  • Format (B x H x T): 159 x 241 x 22 mm
  • Ausgabetyp: Kein, Unbekannt
  • Vorauflage: 978-0-471-23626-9
Autoren/Hrsg.

Autoren

Preface xi

1 Randomization and the Clinical Trial 1

1.1 Introduction 1

1.2 Causation and Association 2

1.3 Randomized Clinical Trials 6

1.4 Ethics of Randomization 9

1.5 Problems 12

1.6 References 13

2 Issues in the Design of Clinical Trials 15

2.1 Introduction 15

2.2 Study Outcomes 15

2.3 Sources of Bias 18

2.3.1 Selection and ascertainment bias 19

2.3.2 Statistical analysis philosophy 20

2.3.3 Losses to follow-up and noncompliance 21

2.3.4 Covariates 21

2.4 Experimental Design 23

2.5 Recruitment and Follow-Up 25

2.6 Determining the Number of Randomized Subjects 26

2.6.1 Development of the main formula 27

2.6.2 Example 29

2.6.3 Survival trials 29

2.6.4 Adjustment for noncompliance 32

2.6.5 Additional considerations 32

2.7 Problems 33

2.8 References 34

3 Randomization for Balancing Treatment Assignments 37

3.1 Introduction 37

3.2 Complete Randomization 38

3.3 Forced Balance Procedures 40

3.3.1 Random allocation rule 40

3.3.2 Truncated binomial design 42

3.3.3 Hadamard randomization 44

3.3.4 Maximal procedure 46

3.4 Forced Balance Randomization Within Blocks 46

3.4.1 Permuted block design 46

3.4.2 Random block design 47

3.5 Efron’s Biased Coin Design 48

3.6 Other Biased Coin Designs and Generalizations 51

3.7 Wei’s Urn Design 52

3.8 Other urn Models and Generalizations 54

3.9 Comparison of Balancing Properties 55

3.10 Restricted Randomization for Unbalanced Allocation 58

3.11 K > 2 Treatments 61

3.12 Problems 62

3.13 References 64

3.14 Appendix 66

4 The Effects of Unobserved Covariates 67

4.1 Introduction 67

4.2 A Bound on the Probability of a Covariate Imbalance 68

4.3 Simulation Results 70

4.4 Accidental Bias 71

4.5