The Design and Analysis of Clinical Experiments (Wiley Series in Probability and Statistics)

Author by : Joseph L. Fleiss
Languange Used : en
Release Date : 2011-01-25
Publisher by : John Wiley & Sons

ISBN :

Description : First published in 1986, this unique reference to clinical experimentation remains just as relevant today. Focusing on the principles of design and analysis of studies on human subjects, this book utilizes and integrates both modern and classical designs. Coverage is limited to experimental comparisons of treatments, or in other words, clinical studies in which treatments are assigned to subjects at random....

Author by : Shein-Chung Chow
Languange Used : en
Release Date : 2013-09-30
Publisher by : John Wiley & Sons

ISBN :

Description : Praise for the Second Edition: “...a grand feast for biostatisticians. It stands readyto satisfy the appetite of any pharmaceutical scientist with arespectable statistical appetite.” —Journal of ClinicalResearch Best Practices The Third Edition of Design and Analysis of ClinicalTrials provides complete, comprehensive, and expanded coverageof recent health treatments and interventions. Featuring a unifiedpresentation, the book provides a well-balanced summary of currentregulatory requirements and recently developed statistical methodsas well as an overview of the various designs and analyses that areutilized at different stages of clinical research and development.Additional features of this Third Edition include: • New chapters on biomarker development and targetclinical trials, adaptive design, trials for evaluating diagnosticdevices, statistical methods for translational medicine, andtraditional Chinese medicine • A balanced overview of current and emerging clinicalissues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrateeveryday applicability, with illustrations and examples to explainkey concepts • New sections on bridging studies and global trials, QTstudies, multinational trials, comparative effectiveness trials,and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical andscientific issues, statistical concepts, and methodologies forbridging clinical and statistical disciplines • An update of each chapter that reflects changes inregulatory requirements for the drug review and approval processand recent developments in statistical design and methodology forclinical research and development Design and Analysis of Clinical Trials, Third Editioncontinues to be an ideal clinical research reference for academic,pharmaceutical, medical, and regulatory scientists/researchers,statisticians, and graduate-level students....

Author by : Shein-Chung Chow
Languange Used : en
Release Date : 2004
Publisher by : Wiley-Interscience

ISBN :

Description : Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references....

Author by : Bradley Huitema
Languange Used : en
Release Date : 2011-10-24
Publisher by : John Wiley & Sons

ISBN :

Description : A complete guide to cutting-edge techniques and best practices for applying covariance analysis methods The Second Edition of Analysis of Covariance and Alternatives sheds new light on its topic, offering in-depth discussions of underlying assumptions, comprehensive interpretations of results, and comparisons of distinct approaches. The book has been extensively revised and updated to feature an in-depth review of prerequisites and the latest developments in the field. The author begins with a discussion of essential topics relating to experimental design and analysis, including analysis of variance, multiple regression, effect size measures and newly developed methods of communicating statistical results. Subsequent chapters feature newly added methods for the analysis of experiments with ordered treatments, including two parametric and nonparametric monotone analyses as well as approaches based on the robust general linear model and reversed ordinal logistic regression. Four groundbreaking chapters on single-case designs introduce powerful new analyses for simple and complex single-case experiments. This Second Edition also features coverage of advanced methods including: Simple and multiple analysis of covariance using both the Fisher approach and the general linear model approach Methods to manage assumption departures, including heterogeneous slopes, nonlinear functions, dichotomous dependent variables, and covariates affected by treatments Power analysis and the application of covariance analysis to randomized-block designs, two-factor designs, pre- and post-test designs, and multiple dependent variable designs Measurement error correction and propensity score methods developed for quasi-experiments, observational studies, and uncontrolled clinical trials Thoroughly updated to reflect the growing nature of the field, Analysis of Covariance and Alternatives is a suitable book for behavioral and medical scineces courses on design of experiments and regression and the upper-undergraduate and graduate levels. It also serves as an authoritative reference work for researchers and academics in the fields of medicine, clinical trials, epidemiology, public health, sociology, and engineering....

Author by : Steven Piantadosi
Languange Used : en
Release Date : 2017-10-09
Publisher by : John Wiley & Sons

ISBN :

Description : Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. This book is accompanied by downloadable files available below under the DOWNLOADS tab. These files include: MATHEMATICA program – A set of downloadable files that tracks the chapters, containing code pertaining to each. SAS PROGRAMS and DATA FILES used in the book. The following software programs, included in the downloadables, were developed by the author, Steven Piantadosi, M.D., Ph.D: RANDOMIZATION – This program generates treatment assignments for a clinical trial using blocked stratified randomization. CRM – Implements the continual reassessment methods for dose finding clinical trials. OPTIMAL – Calculates two-stage optimal phase II designs using the Simon method. POWER – This is a power and sample size program for clinical trials. Executables for installing these programs can also be found at https://risccweb.csmc.edu/biostats/. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease....

Author by : Klaus Hinkelmann
Languange Used : en
Release Date : 2012-02-14
Publisher by : John Wiley & Sons

ISBN :

Description : Provides timely applications, modifications, and extensions of experimental designs for a variety of disciplines Design and Analysis of Experiments, Volume 3: Special Designs and Applications continues building upon the philosophical foundations of experimental design by providing important, modern applications of experimental design to the many fields that utilize them. The book also presents optimal and efficient designs for practice and covers key topics in current statistical research. Featuring contributions from leading researchers and academics, the book demonstrates how the presented concepts are used across various fields from genetics and medicinal and pharmaceutical research to manufacturing, engineering, and national security. Each chapter includes an introduction followed by the historical background as well as in-depth procedures that aid in the construction and analysis of the discussed designs. Topical coverage includes: Genetic cross experiments, microarray experiments, and variety trials Clinical trials, group-sequential designs, and adaptive designs Fractional factorial and search, choice, and optimal designs for generalized linear models Computer experiments with applications to homeland security Robust parameter designs and split-plot type response surface designs Analysis of directional data experiments Throughout the book, illustrative and numerical examples utilize SAS®, JMP®, and R software programs to demonstrate the discussed techniques. Related data sets and software applications are available on the book's related FTP site. Design and Analysis of Experiments, Volume 3 is an ideal textbook for graduate courses in experimental design and also serves as a practical, hands-on reference for statisticians and researchers across a wide array of subject areas, including biological sciences, engineering, medicine, and business....

Author by : Chihiro Hirotsu
Languange Used : en
Release Date : 2017-08-14
Publisher by : John Wiley & Sons

ISBN :

Description : Introducing a revolutionary new model for the statistical analysis of experimental data In this important book, internationally acclaimed statistician, Chihiro Hirotsu, goes beyond classical analysis of variance (ANOVA) model to offer a unified theory and advanced techniques for the statistical analysis of experimental data. Dr. Hirotsu introduces the groundbreaking concept of advanced analysis of variance (AANOVA) and explains how the AANOVA approach exceeds the limitations of ANOVA methods to allow for global reasoning utilizing special methods of simultaneous inference leading to individual conclusions. Focusing on normal, binomial, and categorical data, Dr. Hirotsu explores ANOVA theory and practice and reviews current developments in the field. He then introduces three new advanced approaches, namely: testing for equivalence and non-inferiority; simultaneous testing for directional (monotonic or restricted) alternatives and change-point hypotheses; and analyses emerging from categorical data. Using real-world examples, he shows how these three recognizable families of problems have important applications in most practical activities involving experimental data in an array of research areas, including bioequivalence, clinical trials, industrial experiments, pharmaco-statistics, and quality control, to name just a few. • Written in an expository style which will encourage readers to explore applications for AANOVA techniques in their own research • Focuses on dealing with real data, providing real-world examples drawn from the fields of statistical quality control, clinical trials, and drug testing • Describes advanced methods developed and refined by the author over the course of his long career as research engineer and statistician • Introduces advanced technologies for AANOVA data analysis that build upon the basic ANOVA principles and practices Introducing a breakthrough approach to statistical analysis which overcomes the limitations of the ANOVA model, Advanced Analysis of Variance is an indispensable resource for researchers and practitioners working in fields within which the statistical analysis of experimental data is a crucial research component. Chihiro Hirotsu is a Senior Researcher at the Collaborative Research Center, Meisei University, and Professor Emeritus at the University of Tokyo. He is a fellow of the American Statistical Association, an elected member of the International Statistical Institute, and he has been awarded the Japan Statistical Society Prize (2005) and the Ouchi Prize (2006). His work has been published in Biometrika, Biometrics, and Computational Statistics & Data Analysis, among other premier research journals....