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Introduction To Randomized Controlled Clinical Trials Second Edition

Author: John N.S. Matthews
Publisher: CRC Press
ISBN: 1420011308
Size: 71.68 MB
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Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials provides a concise presentation of the principles applied in this area. It details the concepts behind randomization and methods for designing and analyzing trials and also includes information on meta-analysis and specialized designs, such as cross-over trials, cluster-randomized designs, and equivalence studies. This latest edition features new and revised references, examples, exercises, and a new chapter dedicated to binary outcomes and survival analysis. It also presents numerous examples taken from the medical literature, contains exercises at the end of each chapter, and offers solutions in an appendix. The author uses Minitab and R software throughout the text for implementing the methods that are presented. Comprehensive and accessible, Introduction to Randomized Controlled Clinical Trials is well-suited for those familiar with elementary statistical ideas and methods who want to further their knowledge of the subject.

Introduction To Statistical Methods For Clinical Trials

Author: Thomas D. Cook
Publisher: CRC Press
ISBN: 1584880279
Size: 55.67 MB
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Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Cluster Randomised Trials Second Edition

Author: Richard J. Hayes
Publisher: CRC Press
ISBN: 1315353237
Size: 71.33 MB
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Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.

Clinical Trials

Author: Steven Piantadosi
Publisher: John Wiley & Sons
ISBN: 1118959213
Size: 15.20 MB
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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. 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.

Modern Adaptive Randomized Clinical Trials

Author: Oleksandr Sverdlov
Publisher: CRC Press
ISBN: 1482239892
Size: 56.82 MB
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Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive randomization designs? Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects answers these questions and more. From novel designs to cutting-edge applications, this book presents several new and key developments in adaptive randomization. It also offers a fresh and critical look at a number of already-classical topics. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and the pharmaceutical industry, the text: Clarifies the taxonomy of the concept of adaptive randomization Discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selection Gives an exposition to many novel adaptive randomization techniques such as brick tunnel randomization, targeted least absolute shrinkage and selection operator (LASSO)-based CARA randomization, multi-arm multi-stage (MAMS) designs, to name a few Addresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designs Describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma Explores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects covers a wide spectrum of topics related to adaptive randomization designs in contemporary clinical trials. The book provides a thorough exploration of the merits of adaptive randomization and aids in identifying when it is appropriate to apply such designs in practice.

Applied Stochastic Modelling Second Edition

Author: Byron J.T. Morgan
Publisher: CRC Press
ISBN: 1420011650
Size: 31.83 MB
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Highlighting modern computational methods, Applied Stochastic Modelling, Second Edition provides students with the practical experience of scientific computing in applied statistics through a range of interesting real-world applications. It also successfully revises standard probability and statistical theory. Along with an updated bibliography and improved figures, this edition offers numerous updates throughout. New to the Second Edition An extended discussion on Bayesian methods A large number of new exercises A new appendix on computational methods The book covers both contemporary and classical aspects of statistics, including survival analysis, Kernel density estimation, Markov chain Monte Carlo, hypothesis testing, regression, bootstrap, and generalised linear models. Although the book can be used without reference to computational programs, the author provides the option of using powerful computational tools for stochastic modelling. All of the data sets and MATLAB® and R programs found in the text as well as lecture slides and other ancillary material are available for download at Continuing in the bestselling tradition of its predecessor, this textbook remains an excellent resource for teaching students how to fit stochastic models to data.

Randomization Bootstrap And Monte Carlo Methods In Biology Third Edition

Author: Bryan F.J. Manly
Publisher: CRC Press
ISBN: 9781584885412
Size: 45.95 MB
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Modern computer-intensive statistical methods play a key role in solving many problems across a wide range of scientific disciplines. This new edition of the bestselling Randomization, Bootstrap and Monte Carlo Methods in Biology illustrates the value of a number of these methods with an emphasis on biological applications. This textbook focuses on three related areas in computational statistics: randomization, bootstrapping, and Monte Carlo methods of inference. The author emphasizes the sampling approach within randomization testing and confidence intervals. Similar to randomization, the book shows how bootstrapping, or resampling, can be used for confidence intervals and tests of significance. It also explores how to use Monte Carlo methods to test hypotheses and construct confidence intervals. New to the Third Edition Updated information on regression and time series analysis, multivariate methods, survival and growth data as well as software for computational statistics References that reflect recent developments in methodology and computing techniques Additional references on new applications of computer-intensive methods in biology Providing comprehensive coverage of computer-intensive applications while also offering data sets online, Randomization, Bootstrap and Monte Carlo Methods in Biology, Third Edition supplies a solid foundation for the ever-expanding field of statistics and quantitative analysis in biology.

Introduction To The Theory Of Statistical Inference

Author: Hannelore Liero
Publisher: CRC Press
ISBN: 1466503203
Size: 13.25 MB
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Based on the authors’ lecture notes, Introduction to the Theory of Statistical Inference presents concise yet complete coverage of statistical inference theory, focusing on the fundamental classical principles. Suitable for a second-semester undergraduate course on statistical inference, the book offers proofs to support the mathematics. It illustrates core concepts using cartoons and provides solutions to all examples and problems. Highlights Basic notations and ideas of statistical inference are explained in a mathematically rigorous, but understandable, form Classroom-tested and designed for students of mathematical statistics Examples, applications of the general theory to special cases, exercises, and figures provide a deeper insight into the material Solutions provided for problems formulated at the end of each chapter Combines the theoretical basis of statistical inference with a useful applied toolbox that includes linear models Theoretical, difficult, or frequently misunderstood problems are marked The book is aimed at advanced undergraduate students, graduate students in mathematics and statistics, and theoretically-interested students from other disciplines. Results are presented as theorems and corollaries. All theorems are proven and important statements are formulated as guidelines in prose. With its multipronged and student-tested approach, this book is an excellent introduction to the theory of statistical inference.

Fundamental Concepts For New Clinical Trialists

Author: Scott Evans
Publisher: CRC Press
ISBN: 1498767109
Size: 33.99 MB
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Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

Introduction To General And Generalized Linear Models

Author: Henrik Madsen
Publisher: CRC Press
ISBN: 1439891141
Size: 43.78 MB
Format: PDF, Mobi
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Bridging the gap between theory and practice for modern statistical model building, Introduction to General and Generalized Linear Models presents likelihood-based techniques for statistical modelling using various types of data. Implementations using R are provided throughout the text, although other software packages are also discussed. Numerous examples show how the problems are solved with R. After describing the necessary likelihood theory, the book covers both general and generalized linear models using the same likelihood-based methods. It presents the corresponding/parallel results for the general linear models first, since they are easier to understand and often more well known. The authors then explore random effects and mixed effects in a Gaussian context. They also introduce non-Gaussian hierarchical models that are members of the exponential family of distributions. Each chapter contains examples and guidelines for solving the problems via R. Providing a flexible framework for data analysis and model building, this text focuses on the statistical methods and models that can help predict the expected value of an outcome, dependent, or response variable. It offers a sound introduction to general and generalized linear models using the popular and powerful likelihood techniques. Ancillary materials are available at