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"This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data. It discusses the various kinds of trials that can be found in today's clinical setting including open-labeled trials, multicentered trials, and superiority trials. It also explores such ongoing, cutting-edge trials as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women's health initiative dietary, and AIDS"--Provided by publisher.
List of contents
Contributors xix
Preface xxiii
1 Analysis of Over- and Underdispersed Data 1
2 Analysis of Variance (ANOVA) 10
3 Assessment of Health-Related Quality of Life 26
4 Bandit Processes and Response-Adaptive Clinical Trials: The Art of Exploration Versus Exploitation 40
5 Bayesian Dose-Finding Designs in Healthy Volunteers 51
6 Bootstrap 62
7 Conditional Power in Clinical Trial Monitoring 102
8 Cost-Effectiveness Analysis 111
9 Cox-Type Proportional Hazards Models 126
10 Empirical Likelihood Methods in Clinical Experiments 146
11 Frailty Models 166
12 Futility Analysis 174
13 Imaging Science in Medicine I: Overview 187
14 Imaging Science in Medicine, II: Basics of X-Ray Imaging 213
15 Imaging Science in Medicine, III: Digital (21st Century) X-Ray Imaging 264
16 Intention-to-Treat Analysis 313
17 Interim Analyses 323
18 Interrater Reliability 334
19 Intrarater Reliability 340
20 Kaplan-Meier Plot 357
21 Logistic Regression 365
22 Metadata 380
23 Microarray 392
24 Multi-Armed Bandits, Gittins Index, and Its Calculation 416
25 Multiple Comparisons 436
26 Multiple Evaluators 446
27 Noncompartmental Analysis 457
28 Nonparametric ROC Analysis for Diagnostic Trials 483
29 Optimal Biological Dose for Molecularly Targeted Therapies 496
30 Over- and Underdispersion Models 506
31 Permutation Tests in Clinical Trials 527
32 Pharmacoepidemiology, Overview 536
33 Population Pharmacokinetic and Pharmacodynamic Methods 551
34 Proportions: Inferences and Comparisons 570
35 Publication Bias 595
36 Quality of Life 608
37 Relative Risk Modeing 622
38 Sample Size Considerations for Morbidity/Mortality Trials 633
39 Sample Size for Comparing Means 642
40 Sample Size for Comparing Proportions 653
41 Sample Size for Comparing Time-to-Event Data 664
42 Sample Size for Comparing Variabilities 672
43 Screening, Models of 689
44 Screening Trials 721
45 Secondary Efficacy End Points 731
46 Sensitivity, Specificity, and Receiver Operator Characteristic (ROC) Methods 740
47 Software for Genetics/Genomics 752
48 Stability Study Designs 778
49 Subgroup Analysis 793
50 Survival Analysis, Overview 802
51 The FDA and Regulatory Issues 815
52 The Kappa Index 836
53 Treatment Interruption 846
54 Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice 860
55 U.S. Department of Veterans Affairs Cooperative Studies Program 876
56 Women's Health Initiative: Statistical Aspects and Selected Early Results 901
57 World Health Organization (WHO): Global Health Situation 914
Index 925
About the author
N. BALAKRISHNAN, PHD, is Professor in the Department of Mathematics and Statistics at McMaster University, Canada. He is the author of over twenty books and is the coeditor of
Encyclopedia of Statistical Sciences, Second Edition, also published by Wiley.
Summary
Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials.
