Adaptive Designs

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Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

Gernot Wassmer,Werner Brannath
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials Book PDF

Author : Gernot Wassmer,Werner Brannath
Publisher : Springer
Page : 301 pages
File Size : 46,7 Mb
Release : 2016-07-04
Category : Medical
ISBN : 9783319325620

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Group Sequential and Confirmatory Adaptive Designs in Clinical Trials by Gernot Wassmer,Werner Brannath Pdf

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.

Randomised Response-Adaptive Designs in Clinical Trials

Anthony C Atkinson,Atanu Biswas
Randomised Response Adaptive Designs in Clinical Trials Book PDF

Author : Anthony C Atkinson,Atanu Biswas
Publisher : CRC Press
Page : 341 pages
File Size : 48,5 Mb
Release : 2013-12-26
Category : Mathematics
ISBN : 9781584886938

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Randomised Response-Adaptive Designs in Clinical Trials by Anthony C Atkinson,Atanu Biswas Pdf

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.

Adaptive Design Methods in Clinical Trials

Shein-Chung Chow,Mark Chang
Adaptive Design Methods in Clinical Trials Book PDF

Author : Shein-Chung Chow,Mark Chang
Publisher : CRC Press
Page : 368 pages
File Size : 42,6 Mb
Release : 2011-12-01
Category : Mathematics
ISBN : 9781439839881

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Adaptive Design Methods in Clinical Trials by Shein-Chung Chow,Mark Chang Pdf

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

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

Annpey Pong,Shein-Chung Chow
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development Book PDF

Author : Annpey Pong,Shein-Chung Chow
Publisher : CRC Press
Page : 496 pages
File Size : 50,7 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 1439810176

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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development by Annpey Pong,Shein-Chung Chow Pdf

In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip

Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

Mark Chang
Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio Book PDF

Author : Mark Chang
Publisher : John Wiley & Sons
Page : 280 pages
File Size : 50,5 Mb
Release : 2010-06-15
Category : Medical
ISBN : 9780470438565

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Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio by Mark Chang Pdf

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.

Stage-Wise Adaptive Designs

Shelemyahu Zacks
Stage Wise Adaptive Designs Book PDF

Author : Shelemyahu Zacks
Publisher : John Wiley & Sons
Page : 411 pages
File Size : 49,8 Mb
Release : 2009-05-11
Category : Medical
ISBN : 9780470466940

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Stage-Wise Adaptive Designs by Shelemyahu Zacks Pdf

An expert introduction to stage-wise adaptive designs in all areas of statistics Stage-Wise Adaptive Designs presents the theory and methodology of stage-wise adaptive design across various areas of study within the field of statistics, from sampling surveys and time series analysis to generalized linear models and decision theory. Providing the necessary background material along with illustrative S-PLUS functions, this book serves as a valuable introduction to the problems of adaptive designs. The author begins with a cohesive introduction to the subject and goes on to concentrate on generalized linear models, followed by stage-wise sampling procedures in sampling surveys. Adaptive forecasting in the area of time series analysis is presented in detail, and two chapters are devoted to applications in clinical trials. Bandits problems are also given a thorough treatment along with sequential detection of change-points, sequential applications in industrial statistics, and software reliability. S-Plus functions are available to accompany particular computations, and all examples can be worked out using R, which is available on the book's related FTP site. In addition, a detailed appendix outlines the use of these software functions, while an extensive bibliography directs readers to further research on the subject matter. Assuming only a basic background in statistical topics, Stage-Wise Adaptive Designs is an excellent supplement to statistics courses at the upper-undergraduate and graduate levels. It also serves as a valuable reference for researchers and practitioners in the fields of statistics and biostatistics.

Adaptive Web Design

Aaron Gustafson
Adaptive Web Design Book PDF

Author : Aaron Gustafson
Publisher : New Riders
Page : 385 pages
File Size : 45,9 Mb
Release : 2015-11-21
Category : Computers
ISBN : 9780134216201

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Adaptive Web Design by Aaron Gustafson Pdf

Building an elegant, functional website requires more than just knowing how to code. In Adaptive Web Design, Second Edition, you’ll learn how to use progressive enhancement to build websites that work anywhere, won’t break, are accessible by anyone—on any device—and are designed to work well into the future. This new edition of Adaptive Web Design frames even more of the web design process in the lens of progressive enhancement. You will learn how content strategy, UX, HTML, CSS, responsive web design, JavaScript, server-side programming, and performance optimization all come together in the service of users on whatever device they happen to use to access the web. Understanding progressive enhancement will make you a better web professional, whether you’re a content strategist, information architect, UX designer, visual designer, front-end developer, back-end developer, or project manager. It will enable you to visualize experience as a continuum and craft interfaces that are capable of reaching more users while simultaneously costing less money to develop. When you’ve mastered the tenets and concepts of this book, you will see the web in a whole new way and gain web design superpowers that will make you invaluable to your employer, clients, and the web as a whole. Visit http://adaptivewebdesign.info to learn more.

Adaptive Design Theory and Implementation Using SAS and R

Mark Chang
Adaptive Design Theory and Implementation Using SAS and R Book PDF

Author : Mark Chang
Publisher : CRC Press
Page : 689 pages
File Size : 54,6 Mb
Release : 2014-12-01
Category : Mathematics
ISBN : 9781482256604

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Adaptive Design Theory and Implementation Using SAS and R by Mark Chang Pdf

Get Up to Speed on Many Types of Adaptive DesignsSince 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

Bayesian Adaptive Methods for Clinical Trials

Scott M. Berry,Bradley P. Carlin,J. Jack Lee,Peter Muller
Bayesian Adaptive Methods for Clinical Trials Book PDF

Author : Scott M. Berry,Bradley P. Carlin,J. Jack Lee,Peter Muller
Publisher : CRC Press
Page : 316 pages
File Size : 50,5 Mb
Release : 2010-07-19
Category : Mathematics
ISBN : 9781439825518

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Bayesian Adaptive Methods for Clinical Trials by Scott M. Berry,Bradley P. Carlin,J. Jack Lee,Peter Muller Pdf

Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti

Adaptive Survey Design

Barry Schouten,Andy Peytchev,James Wagner
Adaptive Survey Design Book PDF

Author : Barry Schouten,Andy Peytchev,James Wagner
Publisher : CRC Press
Page : 236 pages
File Size : 48,5 Mb
Release : 2017-07-28
Category : Mathematics
ISBN : 9781498767880

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Adaptive Survey Design by Barry Schouten,Andy Peytchev,James Wagner Pdf

Adaptive survey designs (ASDs) provide a framework for data-driven tailoring of data collection procedures to different sample members, often for cost and bias reduction. People vary in how likely they are to respond and in how they respond. This variation leads to opportunities to selectively deploy design features in order to control both nonresponse and measurement errors. ASD aims at the optimal matching of design features and the characteristics of respondents given the survey budget. Such a goal is sensible, but ASD requires investment in more advanced technical systems and management infrastructure and asks for the collection of relevant auxiliary data. So what are current best practices in ASD? And is ASD worthwhile when the same auxiliary data are employed in the estimation afterwards? In this book, the authors provide answers to these questions, and much more.

Adaptive and Flexible Clinical Trials

Richard Chin
Adaptive and Flexible Clinical Trials Book PDF

Author : Richard Chin
Publisher : CRC Press
Page : 198 pages
File Size : 51,5 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 9781439838334

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Adaptive and Flexible Clinical Trials by Richard Chin Pdf

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon. Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.

Adaptive Control Design and Analysis

Gang Tao
Adaptive Control Design and Analysis Book PDF

Author : Gang Tao
Publisher : John Wiley & Sons
Page : 652 pages
File Size : 55,5 Mb
Release : 2003-07-09
Category : Science
ISBN : 0471274526

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Adaptive Control Design and Analysis by Gang Tao Pdf

A systematic and unified presentation of the fundamentals of adaptive control theory in both continuous time and discrete time Today, adaptive control theory has grown to be a rigorous and mature discipline. As the advantages of adaptive systems for developing advanced applications grow apparent, adaptive control is becoming more popular in many fields of engineering and science. Using a simple, balanced, and harmonious style, this book provides a convenient introduction to the subject and improves one's understanding of adaptive control theory. Adaptive Control Design and Analysis features: Introduction to systems and control Stability, operator norms, and signal convergence Adaptive parameter estimation State feedback adaptive control designs Parametrization of state observers for adaptive control Unified continuous and discrete-time adaptive control L1+a robustness theory for adaptive systems Direct and indirect adaptive control designs Benchmark comparison study of adaptive control designs Multivariate adaptive control Nonlinear adaptive control Adaptive compensation of actuator nonlinearities End-of-chapter discussion, problems, and advanced topics As either a textbook or reference, this self-contained tutorial of adaptive control design and analysis is ideal for practicing engineers, researchers, and graduate students alike.

Climate-Adaptive Design in High Mountain Villages

Carey Clouse
Climate Adaptive Design in High Mountain Villages Book PDF

Author : Carey Clouse
Publisher : Routledge
Page : 302 pages
File Size : 44,8 Mb
Release : 2020-10-15
Category : Nature
ISBN : 9781000205077

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Climate-Adaptive Design in High Mountain Villages by Carey Clouse Pdf

Drawing from the unique context and climate of the Himalaya, this book highlights several innovative design interventions, shaped by a myriad of social, cultural, environmental, and political factors that have been employed in villages to combat climate change. Climate-Adaptive Design in High Mountain Villages focuses on Ladakh, an outpost on the front lines of climate change, and the region’s creative responses to the pressing issues of food security, water management, energy efficiency, design aid, and material resources in the Anthropocene. These strategies – from artificial glaciers to tree armor – showcase the breadth of creative solutions already underway. In doing so, the research addresses the broader concept of climate-adaptive design and how it informs the disciplines of architecture, landscape architecture, and urban planning. An ideal read for academics, researchers, and students in these fields, this book presents a focused investigation into climate-adaptive strategies that could provide transferable solutions for the rest of the world.

Practical Considerations for Adaptive Trial Design and Implementation

Weili He,José Pinheiro,Olga M. Kuznetsova
Practical Considerations for Adaptive Trial Design and Implementation Book PDF

Author : Weili He,José Pinheiro,Olga M. Kuznetsova
Publisher : Springer
Page : 416 pages
File Size : 40,8 Mb
Release : 2014-10-15
Category : Medical
ISBN : 9781493911004

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Practical Considerations for Adaptive Trial Design and Implementation by Weili He,José Pinheiro,Olga M. Kuznetsova Pdf

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

Regenerative-Adaptive Design for Sustainable Development

Phillip B. Roös
Regenerative Adaptive Design for Sustainable Development Book PDF

Author : Phillip B. Roös
Publisher : Springer Nature
Page : 262 pages
File Size : 52,8 Mb
Release : 2020-09-15
Category : Science
ISBN : 9783030532345

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Regenerative-Adaptive Design for Sustainable Development by Phillip B. Roös Pdf

In this book, the author tests a regenerative-adaptive pattern language theory towards investigating the possibilities of a holistic, integrated design and planning method for sustainable development that incorporates the principles of regenerative design, as well as an adaptive pattern language that re-establishes our wholeness with nature, and considers the vulnerabilities of a changing landscape. The book examines an integral approach to contemporary theories of planning and design that explores the human-nature relationship patterns in social and spatial interconnections, between people and their natural environments. The interconnectedness of human and natural systems is used to scaffold possible solutions to address key environmental and sustainability issues that specifically address the need for patterns of behaviour that acknowledge the duality of ‘man and nature’. In 12 chapters, the book presents a holistic, regenerative-adaptive pattern language that encapsulates how communities can better appreciate landscape change under future climate effects, and acknowledges the importance to adapt to patterns of change of place and the environment and therefore inform the communities’ responses for sustainable development. The application of the regenerative-adaptive pattern language was tested along the Great Ocean Road region of the Victorian coast in Australia. The concluding chapters argues that for human settlements and cities to be resilient and sustainable, we must understand the interconnected patterns of human-built environments and natural systems, and how we function in a social-spatial dimension with these. The book is intended for practitioners and academic scholars with interest in sustainable development, regenerative design, pattern languages, biophilia, settlement planning, and climate change adaptation.