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: Cancer Clinical Trials ISBN: 1498706886 ISBN-13(EAN): 9781498706889 Издательство: Taylor&Francis Рейтинг: Цена: 14086.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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.
The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.
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.
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.
Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study.
Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies.
The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement.
Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.
Название: Clinical Trial Optimization using R ISBN: 149873507X ISBN-13(EAN): 9781498735070 Издательство: Taylor&Francis Рейтинг: Цена: 16078.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making.
This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
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: 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.
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