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Transitioning to Good Health and Well-Being addresses critical issues of health in the context of sustainability, which need to be tackled in order to achieve Agenda 2030. Acknowledging the dramatic improvements that have been made in the past decades with regards to health, we also face disparities that remain amongst and within countries. While life expectancy has more than doubled, we are, at the same time, confronted with the challenges that come along with population growth alongside environmental change, migration, ageing, and economic disparities. In its 2018 progress report concerning SDG 3, the UN stated that, while the quality of global health is increasing, “people are still suf...
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
First published in 2002. Routledge is an imprint of Taylor & Francis, an informa company.
"This book provides a focal point for research and real-world data mining practitioners that advance knowledge discovery from low-quality data; it presents in-depth experiences and methodologies, providing theoretical and empirical guidance to users who have suffered from underlying low-quality data. Contributions also focus on interdisciplinary collaborations among data quality, data processing, data mining, data privacy, and data sharing"--Provided by publisher.
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time. Easy-to-Use Techniques and Tools for Real-World Data Modeling The book first shows how the framework allows model representation for different data types, including continuous, categorical, count, and time-to-event data. This leads to the use of generic methods, such as the stochastic approximation of ...
Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subseq...
Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.
Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More ana...