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: Chow, Shein-chung Название: Controversial statistical issues in clinical trials ISBN: 0367576937 ISBN-13(EAN): 9780367576936 Издательство: Taylor&Francis Рейтинг: Цена: 7348.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. It focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development
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 Рейтинг: Цена: 16843.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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: Atkinson, Anthony C , Biswas, Atanu Название: Randomised Response-Adaptive Designs in Clinical Trials ISBN: 0367378973 ISBN-13(EAN): 9780367378974 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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.
Описание: This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products.
Автор: Cook, Prof Jonathan A. (associate Professor, Associate Professor, Centre For Statistics In Medicine, Nuffield Department Of Orthopaedics, Rheumatology Название: Introduction to clinical trials ISBN: 0198885237 ISBN-13(EAN): 9780198885238 Издательство: Oxford Academ Рейтинг: Цена: 6334.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Drug-Drug Interactions ISBN: 036745274X ISBN-13(EAN): 9780367452742 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.
Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:
key interplay between transporters and enzymes in drug metabolism and drug interactions
the integral role of pharmacogenetics in metabolism-based drug-drug interactions
in vivo - in vitro correlations (reversible, mechanism-based inhibition, induction)
in silico approaches enabling structure-activity and structure-function studies
high-throughput screening and GLP methods for evaluating drug interactions in vitro
the use of transgenic animal models to evaluate drug interactions
Providing helpful case examples and computer-aided modeling, Drug-Drug Interactions is filled with over 200 invaluable tables, equations, and figures to clarify key concepts, and incorporates critical new updated information.
Описание: Provides a presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. This book discusses the design and monitoring of Phase II and III clinical trials with time-to-event endpoints.
Описание: Presents a range of solutions to analytic issues. This title reflects developments in methodology with coverage of mixture models and a dataset example. It implements examples using SAS and R code and incorporates a number of examples from real QoL clinical trials to illustrate design and analysis methods.
Автор: Ton J. Cleophas; Aeilko H. Zwinderman; Toine F. Cl Название: Statistics Applied to Clinical Trials ISBN: 1402095228 ISBN-13(EAN): 9781402095221 Издательство: Springer Рейтинг: Цена: 10475.00 р. Наличие на складе: Поставка под заказ.
Описание: Explains classical statistical analysis of clinical trials. This book addresses relatively novel issues, including equivalence testing, interim analysis, sequential analysis, meta-analysis, and provides a framework of the best statistical methods available for such purpose. It is suitable for investigators in the field of clinical trials.
Название: Modern Adaptive Randomized Clinical Trials ISBN: 1482239884 ISBN-13(EAN): 9781482239881 Издательство: Taylor&Francis Рейтинг: Цена: 24499.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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: Hayes Название: Cluster Randomised Trials, Second Edition ISBN: 1498728227 ISBN-13(EAN): 9781498728225 Издательство: Taylor&Francis Рейтинг: Цена: 19906.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Cluster Randomised Trials, Second Edition explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, it covers basic concepts underlying the use of cluster randomisation.
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