Design and Analysis of Clinical Experiments

Emphasizes the strategy of experimentation, data analysis, and the interpretation of experimental results. Features numerous examples using actual engineering and scientific studies. Presents statistics as an integral component of experimentation from the planning stage to the presentation of the conclusions. Deep and concentrated experimental design coverage, with equivalent but separate emphasis on the analysis of data from the various designs. Topics can be implemented by practitioners and do not require a high level of training in statistics. New edition includes new and updated material and computer output.

This user-friendly new edition reflects a modern and accessible approach to experimental design and analysis Design and Analysis of Experiments, Volume 1, Second Edition provides a general introduction to the philosophy, theory, and practice of designing scientific comparative experiments and also details the intricacies that are often encountered throughout the design and analysis processes. With the addition of extensive numerical examples and expanded treatment of key concepts, this book further addresses the needs of practitioners and successfully provides a solid understanding of the relationship between the quality of experimental design and the validity of conclusions. This Second Edition continues to provide the theoretical basis of the principles of experimental design in conjunction with the statistical framework within which to apply the fundamental concepts. The difference between experimental studies and observational studies is addressed, along with a discussion of the various components of experimental design: the error-control design, the treatment design, and the observation design. A series of error-control designs are presented based on fundamental design principles, such as randomization, local control (blocking), the Latin square principle, the split-unit principle, and the notion of factorial treatment structure. This book also emphasizes the practical aspects of designing and analyzing experiments and features: Increased coverage of the practical aspects of designing and analyzing experiments, complete with the steps needed to plan and construct an experiment A case study that explores the various types of interaction between both treatment and blocking factors, and numerical and graphical techniques are provided to analyze and interpret these interactions Discussion of the important distinctions between two types of blocking factors and their role in the process of drawing statistical inferences from an experiment A new chapter devoted entirely to repeated measures, highlighting its relationship to split-plot and split-block designs Numerical examples using SAS® to illustrate the analyses of data from various designs and to construct factorial designs that relate the results to the theoretical derivations Design and Analysis of Experiments, Volume 1, Second Edition is an ideal textbook for first-year 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, pharmacology, psychology, and business.

A comprehensive overview of experimental design at the advanced level The development and introduction of new experimental designs in the last fifty years has been quite staggering and was brought about largely by an ever-widening field of applications. Design and Analysis of Experiments, Volume 2: Advanced Experimental Design is the second of a two-volume body of work that builds upon the philosophical foundations of experimental design set forth half a century ago by Oscar Kempthorne, and features the latest developments in the field. Volume 1: An Introduction to Experimental Design introduced students at the MS level to the principles of experimental design, including the groundbreaking work of R. A. Fisher and Frank Yates, and Kempthorne's work in randomization theory with the development of derived linear models. Design and Analysis of Experiments, Volume 2 provides more detail about aspects of error control and treatment design, with emphasis on their historical development and practical significance, and the connections between them. Designed for advanced-level graduate students and industry professionals, this text includes coverage of: Incomplete block and row-column designs Symmetrical and asymmetrical factorial designs Systems of confounding Fractional factorial designs, including main effect plans Supersaturated designs Robust design or Taguchi experiments Lattice designs Crossover designs In order to facilitate the application of text material to a broad range of fields, the authors take a general approach to their discussions. To aid in the construction and analysis of designs, many procedures are illustrated using Statistical Analysis System (SAS®) software.

Praise for the Second Edition: “…a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

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.

A indispensable guide to understanding and designing modern experiments The tools and techniques of Design of Experiments (DOE) allow researchers to successfully collect, analyze, and interpret data across a wide array of disciplines. Statistical Analysis of Designed Experiments provides a modern and balanced treatment of DOE methodology with thorough coverage of the underlying theory and standard designs of experiments, guiding the reader through applications to research in various fields such as engineering, medicine, business, and the social sciences. The book supplies a foundation for the subject, beginning with basic concepts of DOE and a review of elementary normal theory statistical methods. Subsequent chapters present a uniform, model-based approach to DOE. Each design is presented in a comprehensive format and is accompanied by a motivating example, discussion of the applicability of the design, and a model for its analysis using statistical methods such as graphical plots, analysis of variance (ANOVA), confidence intervals, and hypothesis tests. Numerous theoretical and applied exercises are provided in each chapter, and answers to selected exercises are included at the end of the book. An appendix features three case studies that illustrate the challenges often encountered in real-world experiments, such as randomization, unbalanced data, and outliers. Minitab® software is used to perform analyses throughout the book, and an accompanying FTP site houses additional exercises and data sets. With its breadth of real-world examples and accessible treatment of both theory and applications, Statistical Analysis of Designed Experiments is a valuable book for experimental design courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for practicing statisticians, engineers, and scientists who would like to further their knowledge of DOE.

A valuable guide to conducting experiments and analyzing data across a wide range of applications Experimental design is an important component of the scientific method. This book provides guidance on planning efficient investigations. It compiles designs for a wide range of experimental situations not previously found in accessible form. Focusing on applications in the physical, engineering, biological, and social sciences, Planning, Construction, and Statistical Analysis of Comparative Experiments is a valuable guide to designing experiments and correctly analyzing and interpreting the results. The authors draw on their years of experience in the classroom and as statistical consultants to research programs on campus, in government, and in industry. The object is always to strike the right balance between mathematical necessities and practical constraints. Serving both as a textbook for students of intermediate statistics and a hands-on reference for active researchers, the text includes: A wide range of applications, including agricultural sciences, animal and biomedical sciences, and industrial engineering studies General formulas for estimation and hypothesis testing, presented in a unified and simplified manner Guidelines for evaluating the power and efficiency of designs that are not perfectly balanced New developments in the design of fractional factorials with non-prime numbers of levels in mixed-level fractional factorials Detailed coverage on the construction of plans and the relationship among categories of designs Thorough coverage of balanced, lattice, cyclic, and alpha designs Strategies for sequences of fractional factorials Data sets and SAS® code on a companion web site An ideal handbook for the investigator planning a research program, the text comes complete with detailed plans of experiments and alternative approaches for added flexibility.

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.

State-of-the-art coverage of modern computational methods for the analysis and design of beams Analysis and Design of Elastic Beams presents computer models and applications related to thin-walled beams such as those used in mechanical and aerospace designs, where thin, lightweight structures with high strength are needed. This book will enable readers to compute the cross-sectional properties of individual beams with arbitrary cross-sectional shapes, to apply a general-purpose computer analysis of a complete structure to determine the forces and moments in the individual members, and to use a unified approach for calculating the normal and shear stresses, as well as deflections, for those members' cross sections. In addition, this book augments a solid foundation in the basic structural design theory of beams by: * Providing coverage of thin-wall structure analysis and optimization techniques * Applying computer numerical methods to classical design methods * Developing computational solutions for cross-sectional properties and stresses using finite element analyses Including access to an associated Web site with software for the analysis and design of any cross-sectional shape, Analysis and Design of Elastic Beams: Computational Methods is an essential reference for mechanical, aerospace, and civil engineers and designers working in the automotive, ship, and aerospace industries in product and process design, machine design, structural design, and design optimization, as well as students and researchers in these areas.

This book discusses experimental designs which are very useful in sensory and consumer testing. As an added feature this coverage is fully illustrated with real-life examples. In addition, the importance of fractional factorial designs are explained more fully than in books now available. The heart of this book is product optimization which covers in great detail designs and analysis of optimization studies with consumers. A rundown of this chapter includes: preliminaries, test for adequacy of statistical model and least squares estimation of regression parameters; why use optimization technique; types of optimization experiments; Plackett and Burman design; Box and Behnken design, mixture designs; search for optimum areas in response surfaces; use of contour maps in product reformulation augmentation of fractional factorial design; optimization with discrete variables, dangers of fractional factorial designs, and optimization for robustness. This book will be valuable for a wide audience of professionals in the areas of sensory, marketing, advertising, statistics, quality assurance, food, beverage, personal care, pharmaceutical, household products, and cosmetic industries. The book could also serve as a text in applied statistics