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Biostatistical Methods

by John M. Lachin

Praise for the First Edition". . . an excellent textbook . . . an indispensable reference for biostatisticians and epidemiologists."--International Statistical InstituteA new edition of the definitive guide to classical and modern methods of biostatisticsBiostatistics consists of various quantitative techniques that are essential to the description and evaluation of relationships among biologic and medical phenomena. Biostatistical Methods: The Assessment of Relative Risks, Second Edition develops basic concepts and derives an expanded array of biostatistical methods through the application of both classical statistical tools and more modern likelihood-based theories. With its fluid and balanced presentation, the book guides readers through the important statistical methods for the assessment of absolute and relative risks in epidemiologic studies and clinical trials with categorical, count, and event-time data.Presenting a broad scope of coverage and the latest research on the topic, the author begins with categorical data analysis methods for cross-sectional, prospective, and retrospective studies of binary, polychotomous, and ordinal data. Subsequent chapters present modern model-based approaches that include unconditional and conditional logistic regression; Poisson and negative binomial models for count data; and the analysis of event-time data including the Cox proportional hazards model and its generalizations. The book now includes an introduction to mixed models with fixed and random effects as well as expanded methods for evaluation of sample size and power. Additional new topics featured in this Second Edition include:Establishing equivalence and non-inferiorityMethods for the analysis of polychotomous and ordinal data, including matched data and the Kappa agreement indexMultinomial logistic for polychotomous data and proportional odds models for ordinal dataNegative binomial models for count data as an alternative to the Poisson modelGEE models for the analysis of longitudinal repeated measures and multivariate observationsThroughout the book, SAS is utilized to illustrate applications to numerous real-world examples and case studies. A related website features all the data used in examples and problem sets along with the author's SAS routines.Biostatistical Methods, Second Edition is an excellent book for biostatistics courses at the graduate level. It is also an invaluable reference for biostatisticians, applied statisticians, and epidemiologists.

Randomization in Clinical Trials

by John M. Lachin William F. Rosenberger

Praise for the First Edition "All medical statisticians involved in clinical trials should read this book..." - Controlled Clinical Trials Featuring a unique combination of the 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. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers' 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. 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, as well as 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 in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin 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.

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