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A unique overview that melds the concepts of conditional probability and stochastic processes into real-life applications The role of randomization techniques in clinical trials has become increasingly important. This comprehensive guide combines both the applied aspects of randomization in clinical trials with a probabilistic treatment of properties of randomization. Taking an unabashedly non-Bayesian and nonparametric approach to inference, the book focuses on the linear rank test under a randomization model, with added discussion on likelihood-based inference as it relates to sufficiency and ancillarity. Developments in stochastic processes and applied probability are also given where appropriate. Intuition is stressed over mathematics, but not without a clear development of the latter in the context of the former. Providing a consolidated review of the field, the book includes relevant and practical discussions of: * The benefits of randomization in terms of reduction of bias * Randomization as a basis for inference * Covariate-adaptive and response-adaptive randomization * Current philosophies, controversies, and new developments With ample problem sets, theoretical exercises, and short computer simulations using SAS, Randomization in Clinical Trials: Theory and Practice is equally useful as a standard textbook in biostatistics graduate programs as well as a reliable reference for biostatisticians in practice.

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Randomization in Clinical Trials

Praise for the First Edition «. . . an excellent textbook . . . an indispensable reference for biostatisticians and epidemiologists.» —International Statistical Institute A new edition of the definitive guide to classical and modern methods of biostatistics Biostatistics 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-inferiority Methods for the analysis of polychotomous and ordinal data, including matched data and the Kappa agreement index Multinomial logistic for polychotomous data and proportional odds models for ordinal data Negative binomial models for count data as an alternative to the Poisson model GEE models for the analysis of longitudinal repeated measures and multivariate observations Throughout 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.

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Biostatistical Methods. The Assessment of Relative Risks

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John M. Lachin