Adaptive Design Methods in Clinical Trials, Chow, Shein-Chung

Автор: Lawrence M. Friedman; Curt D. Furberg; David L. De
Название: Fundamentals of Clinical Trials
ISBN: 3319307738 ISBN-13(EAN): 9783319307732
Издательство: Springer
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Цена: 46570.00 T
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Описание: This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.

Автор: Berry, Donald A. Berry, Scott M. Carlin, Bradley P
Название: Bayesian adaptive methods for clinical trials
ISBN: 1439825483 ISBN-13(EAN): 9781439825488
Издательство: Taylor&Francis
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Цена: 112290.00 T
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Описание: Explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. This book summarizes the state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative.

Автор: , Zink Richard C.
Название: Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods
ISBN: 1629593850 ISBN-13(EAN): 9781629593852
Издательство: Неизвестно
Цена: 98030.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Get the tools you need to use SAS(R) 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.

Автор: Atkinson, Anthony C , Biswas, Atanu
Название: Randomised Response-Adaptive Designs in Clinical Trials
ISBN: 0367378973 ISBN-13(EAN): 9780367378974
Издательство: Taylor&Francis
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Цена: 65320.00 T
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Описание:

Randomised Response-Adaptive Designs in Clinical Trials presents methods for the randomised allocation of treatments to patients in sequential clinical trials. Emphasizing the practical application of clinical trial designs, the book is designed for medical and applied statisticians, clinicians, and statisticians in training.

After introducing clinical trials in drug development, the authors assess a simple adaptive design for binary responses without covariates. They discuss randomisation and covariate balance in normally distributed responses and cover many important response-adaptive designs for binary responses. The book then develops response-adaptive designs for continuous and longitudinal responses, optimum designs with covariates, and response-adaptive designs with covariates. It also covers response-adaptive designs that are derived by optimising an objective function subject to constraints on the variance of estimated parametric functions. The concluding chapter explores future directions in the development of adaptive designs.

Автор: Chow, Shein-Chung
Название: Adaptive Design Methods in Clinical Trials
ISBN: 1439839875 ISBN-13(EAN): 9781439839874
Издательство: Taylor&Francis
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Цена: 148010.00 T
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Название: Modern Adaptive Randomized Clinical Trials
ISBN: 1482239884 ISBN-13(EAN): 9781482239881
Издательство: Taylor&Francis
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Цена: 163330.00 T
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Описание: 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.

Автор: Wassmer
Название: Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
ISBN: 3319325604 ISBN-13(EAN): 9783319325606
Издательство: Springer
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Цена: 121110.00 T
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Описание: 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.

Автор: Thomas Ondra
Название: Optimized Response-Adaptive Clinical Trials
ISBN: 3658083433 ISBN-13(EAN): 9783658083434
Издательство: Springer
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Цена: 60940.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Two-armed response-adaptive clinical trials are modelled as Markov decision problems to pursue two overriding objectives: Firstly, to identify the superior treatment at the end of the trial and, secondly, to keep the number of patients receiving the inferior treatment small.

Автор: Wassmer Gernot, Brannath Werner
Название: Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
ISBN: 3319813145 ISBN-13(EAN): 9783319813141
Издательство: Springer
Рейтинг:
Цена: 130430.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.

Автор: Atkinson, Anthony C
Название: Randomised Response-Adaptive Designs in Clinical Trials
ISBN: 1584886935 ISBN-13(EAN): 9781584886938
Издательство: Taylor&Francis
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Цена: 102080.00 T
Наличие на складе: Нет в наличии.

Автор: Balakrishnan
Название: Methods and Applications of Statistics in Clinical Trials: Volume 1 - Concepts, Principles, Trials, and Designs
ISBN: 111830473X ISBN-13(EAN): 9781118304730
Издательство: Wiley
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Цена: 190030.00 T
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Описание: This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data.

Название: Cancer Clinical Trials
ISBN: 1498706886 ISBN-13(EAN): 9781498706889
Издательство: Taylor&Francis
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Цена: 93910.00 T
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Описание:

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials.