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Informationen zum Autor 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 and 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 the Department of Statistics at The George Washington University. He is a fellow of the American Statistical Association and the Society for Clinical Trials and 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. Klappentext Praise for the First Edition : "All medical statisticians involved in clinical trials should read this book..." -Controlled Clinical Trials Featuring a unique combination ofthe 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. A consolidated review of the field, the Second Edition focuses on computation of randomized tests rather than the asymptotic theory of randomized tests. Randomization in Clinical Trials: Theory and Practice, Second Edition features: A discussion on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adjusted response-adaptive randomization, including minimization techniques and inference for covariate-adaptive randomization New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Many problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, to simplify the mathematics, and to ease 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. Zusammenfassung This Second Edition features a unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications. Inhaltsverzeichnis 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...
