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Author: Shelemyahu Zacks
Publisher: John Wiley & Sons
ISBN: 0470466944
Category : Medical
Languages : en
Pages : 411
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Book Description
An expert introduction to stage-wise adaptive designs in all areas of statistics Stage-Wise Adaptive Designs presents the theory and methodology of stage-wise adaptive design across various areas of study within the field of statistics, from sampling surveys and time series analysis to generalized linear models and decision theory. Providing the necessary background material along with illustrative S-PLUS functions, this book serves as a valuable introduction to the problems of adaptive designs. The author begins with a cohesive introduction to the subject and goes on to concentrate on generalized linear models, followed by stage-wise sampling procedures in sampling surveys. Adaptive forecasting in the area of time series analysis is presented in detail, and two chapters are devoted to applications in clinical trials. Bandits problems are also given a thorough treatment along with sequential detection of change-points, sequential applications in industrial statistics, and software reliability. S-Plus functions are available to accompany particular computations, and all examples can be worked out using R, which is available on the book's related FTP site. In addition, a detailed appendix outlines the use of these software functions, while an extensive bibliography directs readers to further research on the subject matter. Assuming only a basic background in statistical topics, Stage-Wise Adaptive Designs is an excellent supplement to statistics courses at the upper-undergraduate and graduate levels. It also serves as a valuable reference for researchers and practitioners in the fields of statistics and biostatistics.
Author: Shelemyahu Zacks
Publisher: John Wiley & Sons
ISBN: 0470466944
Category : Medical
Languages : en
Pages : 411
Get Book Here
Book Description
An expert introduction to stage-wise adaptive designs in all areas of statistics Stage-Wise Adaptive Designs presents the theory and methodology of stage-wise adaptive design across various areas of study within the field of statistics, from sampling surveys and time series analysis to generalized linear models and decision theory. Providing the necessary background material along with illustrative S-PLUS functions, this book serves as a valuable introduction to the problems of adaptive designs. The author begins with a cohesive introduction to the subject and goes on to concentrate on generalized linear models, followed by stage-wise sampling procedures in sampling surveys. Adaptive forecasting in the area of time series analysis is presented in detail, and two chapters are devoted to applications in clinical trials. Bandits problems are also given a thorough treatment along with sequential detection of change-points, sequential applications in industrial statistics, and software reliability. S-Plus functions are available to accompany particular computations, and all examples can be worked out using R, which is available on the book's related FTP site. In addition, a detailed appendix outlines the use of these software functions, while an extensive bibliography directs readers to further research on the subject matter. Assuming only a basic background in statistical topics, Stage-Wise Adaptive Designs is an excellent supplement to statistics courses at the upper-undergraduate and graduate levels. It also serves as a valuable reference for researchers and practitioners in the fields of statistics and biostatistics.
Author: Mark Chang
Publisher: John Wiley & Sons
ISBN: 0470438568
Category : Medical
Languages : en
Pages : 284
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Book Description
ExpDesign Studio facilitates more efficient clinical trial design This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio: Covers both classical and adaptive clinical trial designs, monitoring, and analyses Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples Emphasizes applications, yet covers key mathematical formulations Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. ERRATUM Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio By Mark Chang The license for the ExpDesign Studio software on the CD included with this book is good for one-year after installation of the software. Prior to the expiration of this period, the software will generate a reminder about renewal for the license. The user should contact CTriSoft International (the owners of ExpDesign Studio) at www.CTriSoft.net or by email at
[email protected], about renewal for the license. This should have been made clear in the first printing of this book. We apologize for this error.
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1439839883
Category : Mathematics
Languages : en
Pages : 368
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Book Description
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini
Author: Gernot Wassmer
Publisher: Springer
ISBN: 3319325620
Category : Medical
Languages : en
Pages : 310
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Book Description
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.
Author: Weili He
Publisher: Springer
ISBN: 1493911007
Category : Medical
Languages : en
Pages : 420
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Book Description
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
Author: Sandeep Menon
Publisher: SAS Institute
ISBN: 1629600822
Category : Computers
Languages : en
Pages : 496
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Book Description
Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.
Author: Scott M. Berry
Publisher: CRC Press
ISBN: 1439825513
Category : Mathematics
Languages : en
Pages : 316
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Book Description
Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti
Author: Christopher Jennison
Publisher: CRC Press
ISBN: 9781584888581
Category : Mathematics
Languages : en
Pages : 416
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Book Description
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.
Author: Anne Whitehead
Publisher: John Wiley & Sons
ISBN: 0470854197
Category : Mathematics
Languages : en
Pages : 352
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Book Description
Over the last twenty years there has been a dramatic upsurge in the application of meta-analysis to medical research. This has mainly been due to greater emphasis on evidence-based medicine and the need for reliable summaries of the vast and expanding volume of clinical research. At the same time there have been great strides in the development and refinement of the associated statistical methodology. This book describes the planning, conduct and reporting of a meta-analysis as applied to a series of randomized controlled clinical trials. * The various approaches are presented within a general unified framework. * Meta-analysis techniques are described in detail, from their theoretical development through to practical implementation. * Each topic discussed is supported by detailed worked examples. * A comparison of fixed and random effects approaches is included, as well as a discussion of Bayesian methods and cumulative meta-analysis. * Fully documented programs using standard statistical procedures in SAS are available on the Web. Ideally suited for practising statisticians and statistically-minded medical professionals, the book will also be of use to graduate students of medical statistics. The book is a self-contained and comprehensive account of the subject and an essential purchase for anyone involved in clinical trials.
Author: Bernard Ravina
Publisher: Cambridge University Press
ISBN: 1107376572
Category : Medical
Languages : en
Pages : 387
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Book Description
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.
