Third-variable effect refers to the effect transmitted by third-variables that intervene in the relationship between an exposure and a response variable. Differentiating between the indirect effect of individual factors from multiple third-variables is a constant problem for modern researchers. Statistical Methods for Mediation, Confounding and Moderation Analysis Using R and SAS introduces general definitions of third-variable effects that are adaptable to all different types of response (categorical or continuous), exposure, or third-variables. Using this method, multiple third- variables of different types can be considered simultaneously, and the indirect effect carried by individual third-variables can be separated from the total effect. Readers of all disciplines familiar with introductory statistics will find this a valuable resource for analysis. Key Features: Parametric and nonparametric method in third variable analysis Multivariate and Multiple third-variable effect analysis Multilevel mediation/confounding analysis Third-variable effect analysis with high-dimensional data Moderation/Interaction effect analysis within the third-variable analysis R packages and SAS macros to implement methods proposed in the book

Third-variable effect refers to the effect transmitted by third-variables that intervene in the relationship between an exposure and a response variable. Differentiating between the indirect effect of individual factors from multiple third-variables is a constant problem for modern researchers. Statistical Methods for Mediation, Confounding and Moderation Analysis Using R and SAS introduces general definitions of third-variable effects that are adaptable to all different types of response (categorical or continuous), exposure, or third-variables. Using this method, multiple third- variables of different types can be considered simultaneously, and the indirect effect carried by individual third-variables can be separated from the total effect. Readers of all disciplines familiar with introductory statistics will find this a valuable resource for analysis. Key Features: Parametric and nonparametric method in third variable analysis Multivariate and Multiple third-variable effect analysis Multilevel mediation/confounding analysis Third-variable effect analysis with high-dimensional data Moderation/Interaction effect analysis within the third-variable analysis R packages and SAS macros to implement methods proposed in the book

This book aims to compile typical fundamental-to-advanced statistical methods to be used for health data sciences. Although the book promotes applications to health and health-related data, the models in the book can be used to analyze any kind of data. The data are analyzed with the commonly used statistical software of R/SAS (with online supplementary on SPSS/Stata). The data and computing programs will be available to facilitate readers’ learning experience. There has been considerable attention to making statistical methods and analytics available to health data science researchers and students. This book brings it all together to provide a concise point-of-reference for the most commonly used statistical methods from the fundamental level to the advanced level. We envisage this book will contribute to the rapid development in health data science. We provide straightforward explanations of the collected statistical theory and models, compilations of a variety of publicly available data, and illustrations of data analytics using commonly used statistical software of SAS/R. We will have the data and computer programs available for readers to replicate and implement the new methods. The primary readers would be applied data scientists and practitioners in any field of data science, applied statistical analysts and scientists in public health, academic researchers, and graduate students in statistics and biostatistics. The secondary readers would be R&D professionals/practitioners in industry and governmental agencies. This book can be used for both teaching and applied research.

This book has been replaced by Introduction to Mediation, Moderation, and Conditional Process Analysis, Third Edition, ISBN 978-1-4625-4903-0.

This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.