Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods

Overview

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 ...

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Overview

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.

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Editorial Reviews

Doody's Review Service
Reviewer: Kamesh Sivagnanam, MD (East Tennessee State University Quillen College of Medicine)
Description: The second of a two-volume set on Methods and Applications of Statistics in Clinical Trials, this book focuses on planning, analysis, and inferential methods. Volume 1 covered principles, trials, and designs. This is the seventh entry in the Methods and Applications of Statistics series, edited by N. Balakrishnan, a well-known figure in the field of statistics.
Purpose: The purpose is to provide a detailed discourse on the history, development, and modern advances in planning, analysis, and inferential methods of clinical trials.
Audience: A variety of audiences are served by the book, including those who are interested in understanding the mathematics and concepts behind statistical tests and those who are interested in the planning and execution of a specific type of clinical trial.
Features: The 57 chapters describe a wide variety of subjects including methods of statistical analysis of clinical trials, meta-analysis, data properties and processing, modeling, bias, screening, statistical principles of imaging and micro-arrays, and outcome presentation methods. The overall scope is quite comprehensive. The book is based on the Wiley Encyclopedia of Clinical Trials, but has more updated information. The chapters are arranged alphabetically and hence not organized by content. Chapters are written by different authors, and therefore they do not conform to a uniform structure. However, the book is still arranged in an easy to read fashion. Some chapters have examples where needed and the book is adequately illustrated for concepts, particularly in imaging sciences. The fascinating historical tidbits in the book and the up-to-date modern concepts and methods go hand in hand. Occasionally, the book provides the mathematical background for those interested in understanding the derivations and the theorems that form the backbone of each statistical method. A basic understanding of statistics and calculus is therefore necessary to fully comprehend some material. At the end of each chapter there are multiple references as well as further sources for more information, which is helpful. There are no computational algorithms or codes for statistical software, though some chapters do mention the necessary PROCs for SAS for certain statistical methods. One chapter is also devoted to the statistical methods and results of the women's health initiative.
Assessment: This is a comprehensive book on planning, analysis, and inferential methods in clinical trials and complements the rest of the series.
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Product Details

Meet 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.

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Table 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

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