Design And Analysis Of Bridging Studies
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Design And Analysis Of Bridging Studies
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Author : Jen-pei Liu
language : en
Publisher: CRC Press
Release Date : 2012-07-26
Design And Analysis Of Bridging Studies written by Jen-pei Liu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-26 with Mathematics categories.
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the w
Bayesian Designs For Phase I Ii Clinical Trials
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Author : Ying Yuan
language : en
Publisher: CRC Press
Release Date : 2017-12-19
Bayesian Designs For Phase I Ii Clinical Trials written by Ying Yuan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-19 with Mathematics categories.
Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.
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.
Bayesian Methods In Health Economics
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Author : Gianluca Baio
language : en
Publisher: CRC Press
Release Date : 2012-11-12
Bayesian Methods In Health Economics written by Gianluca Baio and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-12 with Mathematics categories.
Health economics is concerned with the study of the cost-effectiveness of health care interventions. This book provides an overview of Bayesian methods for the analysis of health economic data. After an introduction to the basic economic concepts and methods of evaluation, it presents Bayesian statistics using accessible mathematics. The next chapters describe the theory and practice of cost-effectiveness analysis from a statistical viewpoint, and Bayesian computation, notably MCMC. The final chapter presents three detailed case studies covering cost-effectiveness analyses using individual data from clinical trials, evidence synthesis and hierarchical models and Markov models. The text uses WinBUGS and JAGS with datasets and code available online.
Applied Biclustering Methods For Big And High Dimensional Data Using R
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Author : Adetayo Kasim
language : en
Publisher: CRC Press
Release Date : 2016-08-18
Applied Biclustering Methods For Big And High Dimensional Data Using R written by Adetayo Kasim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-18 with Mathematics categories.
Proven Methods for Big Data Analysis As big data has become standard in many application areas, challenges have arisen related to methodology and software development, including how to discover meaningful patterns in the vast amounts of data. Addressing these problems, Applied Biclustering Methods for Big and High-Dimensional Data Using R shows how to apply biclustering methods to find local patterns in a big data matrix. The book presents an overview of data analysis using biclustering methods from a practical point of view. Real case studies in drug discovery, genetics, marketing research, biology, toxicity, and sports illustrate the use of several biclustering methods. References to technical details of the methods are provided for readers who wish to investigate the full theoretical background. All the methods are accompanied with R examples that show how to conduct the analyses. The examples, software, and other materials are available on a supplementary website.
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.
Interval Censored Time To Event Data
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Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2012-07-19
Interval Censored Time To Event Data written by Ding-Geng (Din) Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-19 with Mathematics categories.
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data. Top biostatisticians from academia, biopharmaceutical industries, and government agencies discuss how these advances are impacting clinical trials and biomedical research. Divided into three parts, the book begins with an overview of interval-censored data modeling, including nonparametric estimation, survival functions, regression analysis, multivariate data analysis, competing risks analysis, and other models for interval-censored data. The next part presents interval-censored methods for current status data, Bayesian semiparametric regression analysis of interval-censored data with monotone splines, Bayesian inferential models for interval-censored data, an estimator for identifying causal effect of treatment, and consistent variance estimation for interval-censored data. In the final part, the contributors use Monte Carlo simulation to assess biases in progression-free survival analysis as well as correct bias in interval-censored time-to-event applications. They also present adaptive decision making methods to optimize the rapid treatment of stroke, explore practical issues in using weighted logrank tests, and describe how to use two R packages. A practical guide for biomedical researchers, clinicians, biostatisticians, and graduate students in biostatistics, this volume covers the latest developments in the analysis and modeling of interval-censored time-to-event data. It shows how up-to-date statistical methods are used in biopharmaceutical and public health applications.
Patient Reported Outcomes
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Author : Joseph C. Cappelleri
language : en
Publisher: CRC Press
Release Date : 2013-12-20
Patient Reported Outcomes written by Joseph C. Cappelleri and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-20 with Mathematics categories.
Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines.
Mixed Effects Models For The Population Approach
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Author : Marc Lavielle
language : en
Publisher: CRC Press
Release Date : 2014-07-14
Mixed Effects Models For The Population Approach written by Marc Lavielle and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-14 with Mathematics categories.
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time. Easy-to-Use Techniques and Tools for Real-World Data Modeling The book first shows how the framework allows model representation for different data types, including continuous, categorical, count, and time-to-event data. This leads to the use of generic methods, such as the stochastic approximation of the EM algorithm (SAEM), for modeling these diverse data types. The book also covers other essential methods, including Markov chain Monte Carlo (MCMC) and importance sampling techniques. The author uses publicly available software tools to illustrate modeling tasks. Methods are implemented in Monolix, and models are visually explored using Mlxplore and simulated using Simulx. Careful Balance of Mathematical Representation and Practical Implementation This book takes readers through the whole modeling process, from defining/creating a parametric model to performing tasks on the model using various mathematical methods. Statisticians and mathematicians will appreciate the rigorous representation of the models and theoretical properties of the methods while modelers will welcome the practical capabilities of the tools. The book is also useful for training and teaching in any field where population modeling occurs.
Clinical And Statistical Considerations In Personalized Medicine
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Author : Claudio Carini
language : en
Publisher: CRC Press
Release Date : 2014-03-27
Clinical And Statistical Considerations In Personalized Medicine written by Claudio Carini and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-03-27 with Mathematics categories.
Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last chapter assesses the regulatory issues involved in using biomarkers. Improve Patient Care and Reduce Costs and Side Effects Despite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.