Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials
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Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials
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Author : Toshiro Tango
language : en
Publisher: CRC Press
Release Date : 2017-09-14
Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials written by Toshiro Tango and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-14 with Mathematics categories.
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials
DOWNLOAD
Author : Toshiro Tango
language : en
Publisher: CRC Press
Release Date : 2017-09-14
Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials written by Toshiro Tango and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-14 with Mathematics categories.
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html
Longitudinal Data Analysis
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Author : Ikuko Funatogawa
language : en
Publisher: Springer
Release Date : 2019-02-04
Longitudinal Data Analysis written by Ikuko Funatogawa and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-04 with Mathematics categories.
This book provides a new analytical approach for dynamic data repeatedly measured from multiple subjects over time. Random effects account for differences across subjects. Auto-regression in response itself is often used in time series analysis. In longitudinal data analysis, a static mixed effects model is changed into a dynamic one by the introduction of the auto-regression term. Response levels in this model gradually move toward an asymptote or equilibrium which depends on covariates and random effects. The book provides relationships of the autoregressive linear mixed effects models with linear mixed effects models, marginal models, transition models, nonlinear mixed effects models, growth curves, differential equations, and state space representation. State space representation with a modified Kalman filter provides log likelihoods for maximum likelihood estimation, and this representation is suitable for unequally spaced longitudinal data. The extension to multivariate longitudinal data analysis is also provided. Topics in medical fields, such as response-dependent dose modifications, response-dependent dropouts, and randomized controlled trials are discussed. The text is written in plain terms understandable for researchers in other disciplines such as econometrics, sociology, and ecology for the progress of interdisciplinary research.
Clinical Trials With Missing Data
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Author : Michael O'Kelly
language : en
Publisher: John Wiley & Sons
Release Date : 2014-02-14
Clinical Trials With Missing Data written by Michael O'Kelly and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-02-14 with Medical categories.
This book provides practical guidance for statisticians, clinicians, and researchers involved in clinical trials in the biopharmaceutical industry, medical and public health organisations. Academics and students needing an introduction to handling missing data will also find this book invaluable. The authors describe how missing data can affect the outcome and credibility of a clinical trial, show by examples how a clinical team can work to prevent missing data, and present the reader with approaches to address missing data effectively. The book is illustrated throughout with realistic case studies and worked examples, and presents clear and concise guidelines to enable good planning for missing data. The authors show how to handle missing data in a way that is transparent and easy to understand for clinicians, regulators and patients. New developments are presented to improve the choice and implementation of primary and sensitivity analyses for missing data. Many SAS code examples are included – the reader is given a toolbox for implementing analyses under a variety of assumptions.
Statistical Methods For Survival Trial Design
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Author : Jianrong Wu
language : en
Publisher: CRC Press
Release Date : 2018-06-14
Statistical Methods For Survival Trial Design written by Jianrong Wu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-14 with Mathematics categories.
Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.
Statistical Topics In Health Economics And Outcomes Research
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Author : Demissie Alemayehu
language : en
Publisher: CRC Press
Release Date : 2017-11-22
Statistical Topics In Health Economics And Outcomes Research written by Demissie Alemayehu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Mathematics categories.
With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.
Cluster Randomised Trials
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Author : Richard J. Hayes
language : en
Publisher: CRC Press
Release Date : 2017-07-06
Cluster Randomised Trials written by Richard J. Hayes and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-06 with Mathematics categories.
Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials
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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2019-03-20
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials written by Mark Chang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-20 with Medical categories.
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Randomization Masking And Allocation Concealment
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Author : Vance Berger
language : en
Publisher: CRC Press
Release Date : 2017-10-30
Randomization Masking And Allocation Concealment written by Vance Berger and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-10-30 with Mathematics categories.
Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these methods correctly. Far too often the subtle nuances that distinguish proper randomization from flawed randomization are completely ignored in trial reports that state only that randomization was used, with no additional information. Experience has shown that in many cases, the type of randomization that was used was flawed. It is only a matter of time before medical journals and regulatory agencies come to realize that we can no longer rely on (or publish) flawed trials, and that flawed randomization in and of itself disqualifies a trial from being robust or high quality, even if that trial is of high quality otherwise. This book will help to clarify the role randomization plays in ensuring internal validity, and in drawing valid inferences from the data. The various chapters cover a variety of randomization methods, and are not limited to the most common (and most flawed) ones. Readers will come away with a profound understanding of what constitutes a valid randomization procedure, so that they can distinguish the valid from the flawed among not only existing methods but also methods yet to be developed.
Clinical Trial Optimization Using R
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Author : Alex Dmitrienko
language : en
Publisher: CRC Press
Release Date : 2017-08-10
Clinical Trial Optimization Using R written by Alex Dmitrienko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-10 with Mathematics categories.
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.