Group Sequential and Confirmatory Adaptive Designs in Clinical Trials PDF Download

Author: Gernot Wassmer
Publisher: Springer
ISBN: 3319325620
Category : Medical
Languages : en
Pages : 310

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Book Description
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.

Author: Anthony C Atkinson
Publisher: CRC Press
ISBN: 1584886935
Category : Mathematics
Languages : en
Pages : 341

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Book Description
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.

Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1439839883
Category : Mathematics
Languages : en
Pages : 368

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Book Description
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

Author: Annpey Pong
Publisher: CRC Press
ISBN: 1439810176
Category : Mathematics
Languages : en
Pages : 475

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Book Description
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

Author: Aaron Gustafson
Publisher: New Riders
ISBN: 0134216202
Category : Computers
Languages : en
Pages : 385

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Book Description
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.

Author: Committee on Adaptation to a Changing Climate
Publisher:
ISBN: 9781523125821
Category : Building, Stormproof
Languages : en
Pages :

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Book Description
Abstract: Prepared by the Committee on Adaptation to a Changing Climate of ASCE Civil infrastructure systems traditionally have been designed for appropriate functionality, durability, and safety for climate and weather extremes during their full-service lives; however, climate scientists inform us that the extremes of climate and weather have altered from historical values in ways difficult to predict or project. Climate-Resilient Infrastructure: Adaptive Design and Risk Management, MOP 140, provides guidance for and contributes to the developing or enhancing of methods for infrastructure analysis and design in a world in which risk profiles are changing and can be projected with varying degrees of uncertainty requiring a new design philosophy to meet this challenge. The underlying approaches in this manual of practice (MOP) are based on probabilistic methods for quantitative risk analysis, and the design framework provided focuses on identifying and analyzing low-regret, adaptive strategies to make a project more resilient. Beginning with an overview of the driving forces and hazards associated with a changing climate, subsequent chapters in MOP 140 provide observational methods, illustrative examples, and case studies; estimation of extreme events particularly related to precipitation with guidance on monitoring and measuring methods; flood design criteria and the development of project design flood elevations; computational methods of determining flood loads; adaptive design and adaptive risk management in the context of life-cycle engineering and economics; and climate resilience technologies. MOP 140 will be of interest to engineers, researchers, planners, and other stakeholders charged with adaptive design decisions to achieve infrastructure resilience targets while minimizing life-cycle costs in a changing climate

Author: Scott M. Berry
Publisher: CRC Press
ISBN: 1439825513
Category : Mathematics
Languages : en
Pages : 316

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Book Description
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

Author: Barry Schouten
Publisher: CRC Press
ISBN: 1498767885
Category : Mathematics
Languages : en
Pages : 267

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Book Description
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.

Author: Guosheng Yin
Publisher: John Wiley & Sons
ISBN: 1118183320
Category : Medical
Languages : en
Pages : 368

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Book Description
A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.

Author: Gang Tao
Publisher: John Wiley & Sons
ISBN: 9780471274520
Category : Science
Languages : en
Pages : 652

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Book Description
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.