Methods and Applications of Statistics in Clinical Trials, Volume 2

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.

“This book provides a good overview on most relevant topics for clinical trials.”  (Biometrical Journal, 1 October 2015)

• Contributors xix Preface xxiii1 Analysis of Over- and Underdispersed Data 12 Analysis of Variance (ANOVA) 103 Assessment of Health-Related Quality of Life 264 Bandit Processes and Response-Adaptive Clinical Trials: The Art of Exploration Versus Exploitation 405 Bayesian Dose-Finding Designs in Healthy Volunteers 516 Bootstrap 627 Conditional Power in Clinical Trial Monitoring 1028 Cost-Effectiveness Analysis 1119 Cox-Type Proportional Hazards Models 12610 Empirical Likelihood Methods in Clinical Experiments 14611 Frailty Models 16612 Futility Analysis 17413 Imaging Science in Medicine I: Overview 18714 Imaging Science in Medicine, II: Basics of X-Ray Imaging 21315 Imaging Science in Medicine, III: Digital (21st Century) X-Ray Imaging 26416 Intention-to-Treat Analysis 31317 Interim Analyses 32318 Interrater Reliability 33419 Intrarater Reliability 34020 Kaplan-Meier Plot 35721 Logistic Regression 36522 Metadata 38023 Microarray 39224 Multi-Armed Bandits, Gittins Index, and Its Calculation 41625 Multiple Comparisons 43626 Multiple Evaluators 44627 Noncompartmental Analysis 45728 Nonparametric ROC Analysis for Diagnostic Trials 48329 Optimal Biological Dose for Molecularly Targeted Therapies 49630 Over- and Underdispersion Models 50631 Permutation Tests in Clinical Trials 52732 Pharmacoepidemiology, Overview 53633 Population Pharmacokinetic and Pharmacodynamic Methods 55134 Proportions: Inferences and Comparisons 57035 Publication Bias 59536 Quality of Life 60837 Relative Risk Modeing 62238 Sample Size Considerations for Morbidity/Mortality Trials 63339 Sample Size for Comparing Means 64240 Sample Size for Comparing Proportions 65341 Sample Size for Comparing Time-to-Event Data 66442 Sample Size for Comparing Variabilities 67243 Screening, Models of 68944 Screening Trials 72145 Secondary Efficacy End Points 73146 Sensitivity, Specificity, and Receiver Operator Characteristic (ROC) Methods 74047 Software for Genetics/Genomics 75248 Stability Study Designs 77849 Subgroup Analysis 79350 Survival Analysis, Overview 80251 The FDA and Regulatory Issues 81552 The Kappa Index 83653 Treatment Interruption 84654 Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice 86055 U.S. Department of Veterans Affairs Cooperative Studies Program 87656 Women's Health Initiative: Statistical Aspects and Selected Early Results 90157 World Health Organization (WHO): Global Health Situation 914Index 925