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Sequential Experimentation In Clinical Trials
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Book Synopsis Sequential Experimentation in Clinical Trials by : Jay Bartroff
Download or read book Sequential Experimentation in Clinical Trials written by Jay Bartroff and published by Springer Science & Business Media. This book was released on 2012-12-12 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.
Book Synopsis Sequential Medical Trials by : P. Armitage
Download or read book Sequential Medical Trials written by P. Armitage and published by John Wiley & Sons. This book was released on 1975 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Design and Analysis of Sequential Clinical Trials by : John Whitehead
Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by Horwood Publishing Limited. This book was released on 1983 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results.
Book Synopsis Group Sequential Methods with Applications to Clinical Trials by : Christopher Jennison
Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by . This book was released on 2000 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion.Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models.Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.
Book Synopsis The Logic of Adaptive Sequential Experimentation in Policy Design by : Haipeng Xing
Download or read book The Logic of Adaptive Sequential Experimentation in Policy Design written by Haipeng Xing and published by Intl Food Policy Res Inst. This book was released on 2013-06-26 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inspired by the wide adoption of rigorous randomized controlled trials (RCTs) in medical research, economists and other social scientists have increasingly used RCTs in their research. As researchers pick up projects amenable to the RCT methodology, they likely leave out important questions to which RCTs cannot be directly applied. As a result, RCTs have been criticized for the proclivity of addressing trivial questions. As a matter of fact, in medical research RCTs are an integral part of adaptive sequential experiment designa few steps must be taken to screen out drugs that have toxins and strong side effects before running any RCTs on humans. In this paper, we argue that economists can learn a great deal from the design principles implemented in medical research. We develop a theoretical model to show the logic of adaptive sequential experiment design in the presence of uncertainty over negative effects and discuss how to choose samples in a population to minimize the experiment cost. We also point out the applications of our proposed framework in the economic domain, such as economic reforms and new product design.
Book Synopsis Design and Analysis of Clinical Experiments by : Joseph L. Fleiss
Download or read book Design and Analysis of Clinical Experiments written by Joseph L. Fleiss and published by John Wiley & Sons. This book was released on 2011-01-25 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Group Sequential and Confirmatory Adaptive Designs in Clinical Trials by : Gernot Wassmer
Download or read book Group Sequential and Confirmatory Adaptive Designs in Clinical Trials written by Gernot Wassmer and published by Springer. This book was released on 2016-07-04 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.
Book Synopsis Adaptive Designs for Sequential Treatment Allocation by : Alessandro Baldi Antognini
Download or read book Adaptive Designs for Sequential Treatment Allocation written by Alessandro Baldi Antognini and published by CRC Press. This book was released on 2015-04-06 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory. The book focuses on designing sequential randomized experiments to compare two or more treatments incorporating information accrued along the way. The authors first introduce the termin
Book Synopsis Principles of Experimental Design for the Life Sciences by : Murray R. Selwyn
Download or read book Principles of Experimental Design for the Life Sciences written by Murray R. Selwyn and published by CRC Press. This book was released on 1996-05-23 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Let this down-to-earth book be your guide to the statistical integrity of your work. Without relying on the detailed and complex mathematical explanations found in many other statistical texts, Principles of Experimental Design for the Life Sciences teaches how to design, conduct, and interpret top-notch life science studies. Learn about the planning of biomedical studies, the principles of statistical design, sample size estimation, common designs in biological experiments, sequential clinical trials, high dimensional designs and process optimization, and the correspondence between objectives, design, and analysis. Each of these important topics is presented in an understandable and non-technical manner, free of statistical jargon and formulas. Written by a biostatistical consultant with 25 years of experience, Principles of Experimental Design for the Life Sciences is filled with real-life examples from the author's work that you can quickly and easily apply to your own. These examples illustrate the main concepts of experimental design and cover a broad range of application areas in both clinical and nonclinical research. With this one innovative, helpful book you can improve your understanding of statistics, enhance your confidence in your results, and, at long last, shake off those statistical shackles!
Book Synopsis The Design and Analysis of Sequential Clinical Trials by : John Whitehead
Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by John Wiley & Sons. This book was released on 1997-08-04 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results. Emphasis is placed on the triangular test and other procedures based on straight line stopping boundaries. These methods allow for frequent or occasional interim analyses and permit the analysis of a wide variety of patient responses. Alternative procedures are also covered in detail, and these include -spending function methods, repeated confidence intervals and Bayesian approaches to sequential clinical trials.
Book Synopsis A Sequential Clinical Trial for Testing P1 by : David Siegmund
Download or read book A Sequential Clinical Trial for Testing P1 written by David Siegmund and published by . This book was released on 1979 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sequential Analysis and Optimal Design by : Herman Chernoff
Download or read book Sequential Analysis and Optimal Design written by Herman Chernoff and published by SIAM. This book was released on 1972-01-01 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: An exploration of the interrelated fields of design of experiments and sequential analysis with emphasis on the nature of theoretical statistics and how this relates to the philosophy and practice of statistics.
Book Synopsis Statistical Methods for Evaluating Safety in Medical Product Development by : A. Lawrence Gould
Download or read book Statistical Methods for Evaluating Safety in Medical Product Development written by A. Lawrence Gould and published by John Wiley & Sons. This book was released on 2014-12-08 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code
Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger
Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book…” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.
Book Synopsis Sequential Medical Trials for Comparing an Experimental with a Standard Treatment by : A. John Petkau
Download or read book Sequential Medical Trials for Comparing an Experimental with a Standard Treatment written by A. John Petkau and published by . This book was released on 1975 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: The research is concerned with a cost function approach to the design of sequential medical trials for comparing an experimental with a standard treatment. It is assumed that all available patients must be treated with one of the two treatments. The standard and experimental treatments are characterized by known and unknown probabilities of success respectively. Two costs are considered; the cost incurred every time either of the treatments fails and a special cost per patient treated in the experimental portion of the plan.
Book Synopsis Translational and Experimental Clinical Research by : Daniel P. Schuster
Download or read book Translational and Experimental Clinical Research written by Daniel P. Schuster and published by Lippincott Williams & Wilkins. This book was released on 2005 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is a comprehensive textbook for investigators entering the rapidly growing field of translational and experimental clinical research. The book offers detailed guidelines for designing and conducting a study and analyzing and reporting results and discusses key ethical and regulatory issues. Chapters address specific types of studies such as clinical experiments in small numbers of patients, pharmacokinetics and pharmacodynamics, and gene therapy and pharmacogenomic studies. A major section describes modern techniques of translational clinical research, including gene expression, identifying mutations and polymorphisms, cloning, transcriptional profiling, proteomics, cell and tissue imaging, tissue banking, evaluating substrate metabolism, and in vivo imaging.
Book Synopsis Clinical Trials in Neurology by : Bernard Ravina
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
