Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2

N. BALAKRISHNAN is Professor in the Department of Mathematics and Statistics at McMaster University, Canada. He is a Fellow of the American Statistical Association. His publications include other Wiley books: A First Course in Order Statistics, Continuous Univariate Distributions - 1 & 2, and Discrete Multivariate Distributions.

• VOLUME 1Contributors xxiiiPreface xxix1 Absolute Risk Reduction 12 Accelerated Approval 143 AIDS Clinical Trials Group (ACTG) 274 Algorithm-Based Designs 405 Alpha-Spending Function 536 Application of New Designs in Phase I Trials 657 ASCOT Trial 748 Benefit/Risk Assessment in Prevention Trials 809 Biased Coin Randomization 9010 Biological Assay, Overview 10611 Block Randomization 12512 Censored Data 13913 Clinical Data Coordination 14614 Clinical Data Management 16415 Clinical Significance 17016 Clinical Trial Misconduct 19117 Clinical Trials, Early Cancer and Heart Disease 20518 Cluster Randomization 21619 Coherence in Phase I Clinical Trials 23020 Compliance and Survival Analysis 24021 Composite Endpoints in Clinical Trials 24622 Confounding 25223 Control Groups 26324 Coronary Drug Project 27325 Covariates 28526 Crossover Design 30027 Crossover Trials 31028 Diagnostic Studies 32029 DNA Bank 34030 Up-and-Down and Escalation Designs 35331 Dose Ranging Crossover Designs 36232 Flexible Designs 38333 Gene Therapy 39934 Global Assessment Variables 42335 Good Clinical Practice (GCP) 43836 Group-Randomized Trials 44837 Group Sequential Designs 46738 Hazard Ratio 48339 Large Simple Trials 50040 Longitudinal Data 51041 Maximum Duration and Information Trials 51542 Missing Data 52243 Mother to Child Human Immunodeficiency Virus Transmission Trials 53644 Multiple Testing in Clinical Trials 55045 Multicenter Trials 55846 Multiple Endpoints 57047 Multiple Risk Factor Intervention Trial 57748 N-of-1 Randomized Trials 58749 Noninferiority Trial 59850 Nonrandomized Trials 60951 Open-Labeled Trials 61952 Optimizing Schedule of Administration in Phase I Clinical Trials 62553 Partially Balanced Designs 63554 Phase I/II Clinical Trials 65855 Phase II/III Trials 66756 Phase I Trials 68257 Phase II Trials 69258 Phase III Trials 70059 Phase IV Trials 71160 Phase I Trials in Oncology 71961 Placebos 72562 Planning a Group-Randomized Trial 73663 Postmenopausal Estrogen/Progestin Interventions Trial (PEPI) 74464 Preference Trials 75965 Prevention Trials 77066 Primary Efficacy Endpoint 77967 Prognostic Variables in Clinical Trials 78968 Randomization Procedures 79969 Randomization Schedule 81370 Repeated Measurements 82771 Simple Randomization 84172 Subgroups 85073 Superiority Trials 86774 Surrogate Endpoints 87875 TNT Trial 88776 UGDP Trial 89477 Women's Health Initiative Hormone Therapy Trials 91878 Women's Health Initiative Dietary Modification Trial 931Index 945VOLUME 2Contributors xixPreface 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