Adaptive Design Theory And Implementation Using Sas And R

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Adaptive Design Theory And Implementation Using Sas And R

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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2012-10-09

Adaptive Design Theory And Implementation Using Sas And R 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 2012-10-09 with Mathematics categories.

Adaptive design has become an important tool in modern pharmaceutical research and development. Compared to a classic trial design with static features, an adaptive design allows for the modification of the characteristics of ongoing trials based on cumulative information. Adaptive designs increase the probability of success, reduce costs and the t

Adaptive Design Theory And Implementation Using Sas And R Second Edition

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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2014-12-01

Adaptive Design Theory And Implementation Using Sas And R Second Edition 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 2014-12-01 with Mathematics categories.

Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

Classical And Adaptive Clinical Trial Designs Using Expdesign Studio

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Author : Mark Chang
language : en
Publisher: John Wiley & Sons
Release Date : 2010-06-15

Classical And Adaptive Clinical Trial Designs Using Expdesign Studio written by Mark Chang 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 2010-06-15 with Medical categories.

ExpDesign Studio facilitates more efficient clinical trial design This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio: Covers both classical and adaptive clinical trial designs, monitoring, and analyses Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples Emphasizes applications, yet covers key mathematical formulations Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. ERRATUM Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio By Mark Chang The license for the ExpDesign Studio software on the CD included with this book is good for one-year after installation of the software. Prior to the expiration of this period, the software will generate a reminder about renewal for the license. The user should contact CTriSoft International (the owners of ExpDesign Studio) at www.CTriSoft.net or by email at [email protected], about renewal for the license. This should have been made clear in the first printing of this book. We apologize for this error.

Adaptive Design Methods In Clinical Trials

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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2011-12-01

Adaptive Design Methods In Clinical Trials written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-01 with Mathematics categories.

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini

Clinical Trial Data Analysis Using R And Sas

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Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2017-06-01

Clinical Trial Data Analysis Using R And Sas 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 2017-06-01 with Mathematics categories.

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

Introductory Adaptive Trial Designs

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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2015-05-21

Introductory Adaptive Trial Designs 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 2015-05-21 with Mathematics categories.

All the Essentials to Start Using Adaptive Designs in No TimeCompared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to quickly and easily grasp the essence of adaptive desig

Applied Surrogate Endpoint Evaluation Methods With Sas And R

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Author : Ariel Alonso
language : en
Publisher: CRC Press
Release Date : 2016-11-30

Applied Surrogate Endpoint Evaluation Methods With Sas And R written by Ariel Alonso and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-30 with Mathematics categories.

An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

Group Sequential And Confirmatory Adaptive Designs In Clinical Trials

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Author : Gernot Wassmer
language : en
Publisher: Springer
Release Date : 2016-07-04

Group Sequential And Confirmatory Adaptive Designs In Clinical Trials written by Gernot Wassmer and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-04 with Medical categories.

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.

Confidence Intervals For Proportions And Related Measures Of Effect Size

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Author : Robert Gordon Newcombe
language : en
Publisher: CRC Press
Release Date : 2012-08-25

Confidence Intervals For Proportions And Related Measures Of Effect Size written by Robert Gordon Newcombe and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-08-25 with Mathematics categories.

Confidence Intervals for Proportions and Related Measures of Effect Size illustrates the use of effect size measures and corresponding confidence intervals as more informative alternatives to the most basic and widely used significance tests. The book provides you with a deep understanding of what happens when these statistical methods are applied

Methods In Comparative Effectiveness Research

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Author : Constantine Gatsonis
language : en
Publisher: CRC Press
Release Date : 2017-02-24

Methods In Comparative Effectiveness Research written by Constantine Gatsonis and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Mathematics categories.

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.