Sequential Experimentation In Clinical Trials

Author : Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih
Publisher : Springer Science & Business Media
Page : 250 pages
File Size : 40,5 Mb
Release : 2012-12-12
Category : Medical
ISBN : 9781461461142

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Sequential Experimentation in Clinical Trials by Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih Pdf

Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.

Author : P. Armitage
Publisher : John Wiley & Sons
Page : 216 pages
File Size : 43,8 Mb
Release : 1975
Category : Medical
ISBN : UOM:39015003218552

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Sequential Medical Trials by P. Armitage Pdf

Author : John Whitehead
Publisher : Horwood Publishing Limited
Page : 280 pages
File Size : 43,5 Mb
Release : 1983
Category : Health & Fitness
ISBN : UOM:39015015600102

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The Design and Analysis of Sequential Clinical Trials by John Whitehead Pdf

This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results.

Author : Christopher Jennison
Publisher : Unknown
Page : 390 pages
File Size : 47,6 Mb
Release : 2000
Category : MEDICAL
ISBN : 0367805324

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Group Sequential Methods with Applications to Clinical Trials by Christopher Jennison Pdf

Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion.Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models.Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

Author : Haipeng Xing,Xiaobo Zhang
Publisher : Intl Food Policy Res Inst
Page : 28 pages
File Size : 47,6 Mb
Release : 2013-06-26
Category : Social Science
ISBN : 8210379456XXX

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The Logic of Adaptive Sequential Experimentation in Policy Design by Haipeng Xing,Xiaobo Zhang Pdf

Inspired by the wide adoption of rigorous randomized controlled trials (RCTs) in medical research, economists and other social scientists have increasingly used RCTs in their research. As researchers pick up projects amenable to the RCT methodology, they likely leave out important questions to which RCTs cannot be directly applied. As a result, RCTs have been criticized for the proclivity of addressing trivial questions. As a matter of fact, in medical research RCTs are an integral part of adaptive sequential experiment design—a few steps must be taken to screen out drugs that have toxins and strong side effects before running any RCTs on humans. In this paper, we argue that economists can learn a great deal from the design principles implemented in medical research. We develop a theoretical model to show the logic of adaptive sequential experiment design in the presence of uncertainty over negative effects and discuss how to choose samples in a population to minimize the experiment cost. We also point out the applications of our proposed framework in the economic domain, such as economic reforms and new product design.

Author : Gernot Wassmer,Werner Brannath
Publisher : Springer
Page : 301 pages
File Size : 52,9 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.

Author : Joseph L. Fleiss
Publisher : John Wiley & Sons
Page : 458 pages
File Size : 51,6 Mb
Release : 2011-01-25
Category : Mathematics
ISBN : 9781118031179

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Design and Analysis of Clinical Experiments by Joseph L. Fleiss Pdf

First published in 1986, this unique reference to clinical experimentation remains just as relevant today. Focusing on the principles of design and analysis of studies on human subjects, this book utilizes and integrates both modern and classical designs. Coverage is limited to experimental comparisons of treatments, or in other words, clinical studies in which treatments are assigned to subjects at random.

Author : Murray R. Selwyn
Publisher : CRC Press
Page : 176 pages
File Size : 42,6 Mb
Release : 1996-05-23
Category : Science
ISBN : 0849394619

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Principles of Experimental Design for the Life Sciences by Murray R. Selwyn Pdf

Let this down-to-earth book be your guide to the statistical integrity of your work. Without relying on the detailed and complex mathematical explanations found in many other statistical texts, Principles of Experimental Design for the Life Sciences teaches how to design, conduct, and interpret top-notch life science studies. Learn about the planning of biomedical studies, the principles of statistical design, sample size estimation, common designs in biological experiments, sequential clinical trials, high dimensional designs and process optimization, and the correspondence between objectives, design, and analysis. Each of these important topics is presented in an understandable and non-technical manner, free of statistical jargon and formulas. Written by a biostatistical consultant with 25 years of experience, Principles of Experimental Design for the Life Sciences is filled with real-life examples from the author's work that you can quickly and easily apply to your own. These examples illustrate the main concepts of experimental design and cover a broad range of application areas in both clinical and nonclinical research. With this one innovative, helpful book you can improve your understanding of statistics, enhance your confidence in your results, and, at long last, shake off those statistical shackles!

Author : John Whitehead
Publisher : John Wiley & Sons
Page : 342 pages
File Size : 45,8 Mb
Release : 1997-08-04
Category : Science
ISBN : 0471975508

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The Design and Analysis of Sequential Clinical Trials by John Whitehead Pdf

This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results. Emphasis is placed on the triangular test and other procedures based on straight line stopping boundaries. These methods allow for frequent or occasional interim analyses and permit the analysis of a wide variety of patient responses. Alternative procedures are also covered in detail, and these include -spending function methods, repeated confidence intervals and Bayesian approaches to sequential clinical trials.

Author : A. Lawrence Gould
Publisher : John Wiley & Sons
Page : 392 pages
File Size : 45,8 Mb
Release : 2014-12-08
Category : Medical
ISBN : 9781118763094

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Statistical Methods for Evaluating Safety in Medical Product Development by A. Lawrence Gould Pdf

This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Author : R. Mead,S. G. Gilmour,A. Mead
Publisher : Cambridge University Press
Page : 587 pages
File Size : 42,6 Mb
Release : 2012-09-13
Category : Mathematics
ISBN : 9781139576642

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Statistical Principles for the Design of Experiments by R. Mead,S. G. Gilmour,A. Mead Pdf

This book is about the statistical principles behind the design of effective experiments and focuses on the practical needs of applied statisticians and experimenters engaged in design, implementation and analysis. Emphasising the logical principles of statistical design, rather than mathematical calculation, the authors demonstrate how all available information can be used to extract the clearest answers to many questions. The principles are illustrated with a wide range of examples drawn from real experiments in medicine, industry, agriculture and many experimental disciplines. Numerous exercises are given to help the reader practise techniques and to appreciate the difference that good design can make to an experimental research project. Based on Roger Mead's excellent Design of Experiments, this new edition is thoroughly revised and updated to include modern methods relevant to applications in industry, engineering and modern biology. It also contains seven new chapters on contemporary topics, including restricted randomisation and fractional replication.

Author : Lee-jen Wei
Publisher : Unknown
Page : 262 pages
File Size : 45,8 Mb
Release : 1975
Category : Sequential analysis
ISBN : WISC:89010842656

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The Design of Sequential Experiments by Lee-jen Wei Pdf

Author : Lucien Marie Le Cam,Jerzy Neyman
Publisher : Univ of California Press
Page : 964 pages
File Size : 44,5 Mb
Release : 1967
Category : Biometry
ISBN : 8210379456XXX

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Proceedings of the Fifth Berkeley Symposium on Mathematical Statistics and Probability by Lucien Marie Le Cam,Jerzy Neyman Pdf

Author : Alessandro Baldi Antognini,Alessandra Giovagnoli
Publisher : CRC Press
Page : 216 pages
File Size : 46,8 Mb
Release : 2015-04-06
Category : Mathematics
ISBN : 9781466505766

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Adaptive Designs for Sequential Treatment Allocation by Alessandro Baldi Antognini,Alessandra Giovagnoli Pdf

Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory. The book focuses on designing sequential randomized experiments to compare two or more treatments incorporating information accrued along the way. The authors first introduce the termin

Author : A. John Petkau
Publisher : Unknown
Page : 256 pages
File Size : 48,7 Mb
Release : 1975
Category : Brownian motion processes
ISBN : STANFORD:36105005009613

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Sequential Medical Trials for Comparing an Experimental with a Standard Treatment by A. John Petkau Pdf

The research is concerned with a cost function approach to the design of sequential medical trials for comparing an experimental with a standard treatment. It is assumed that all available patients must be treated with one of the two treatments. The standard and experimental treatments are characterized by known and unknown probabilities of success respectively. Two costs are considered; the cost incurred every time either of the treatments fails and a special cost per patient treated in the experimental portion of the plan.