Sequential Experimentation In Clinical Trials


Sequential Experimentation In Clinical Trials
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Sequential Experimentation In Clinical Trials


Sequential Experimentation In Clinical Trials
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Author : Jay Bartroff
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-12

Sequential Experimentation In Clinical Trials written by Jay Bartroff and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-12 with Medical categories.


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.



Sequential Medical Trials


Sequential Medical Trials
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Author : P. Armitage
language : en
Publisher: John Wiley & Sons
Release Date : 1975

Sequential Medical Trials written by P. Armitage 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 1975 with Medical categories.




The Logic Of Adaptive Sequential Experimentation In Policy Design


The Logic Of Adaptive Sequential Experimentation In Policy Design
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Author : Haipeng Xing
language : en
Publisher: Intl Food Policy Res Inst
Release Date : 2013-06-26

The Logic Of Adaptive Sequential Experimentation In Policy Design written by Haipeng Xing and has been published by Intl Food Policy Res Inst this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-26 with Social Science categories.


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.



Group Sequential Methods With Applications To Clinical Trials


Group Sequential Methods With Applications To Clinical Trials
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Author : Christopher Jennison
language : en
Publisher:
Release Date : 2000

Group Sequential Methods With Applications To Clinical Trials written by Christopher Jennison and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with MEDICAL categories.


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.



The Design And Analysis Of Sequential Clinical Trials


The Design And Analysis Of Sequential Clinical Trials
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Author : John Whitehead
language : en
Publisher: Horwood Publishing Limited
Release Date : 1983

The Design And Analysis Of Sequential Clinical Trials written by John Whitehead and has been published by Horwood Publishing Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 1983 with Health & Fitness categories.


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.



Principles Of Experimental Design For The Life Sciences


Principles Of Experimental Design For The Life Sciences
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Author : Murray R. Selwyn
language : en
Publisher: CRC Press
Release Date : 1996-05-23

Principles Of Experimental Design For The Life Sciences written by Murray R. Selwyn and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-05-23 with Science categories.


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!



Design And Analysis Of Clinical Experiments


Design And Analysis Of Clinical Experiments
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Author : Joseph L. Fleiss
language : en
Publisher: John Wiley & Sons
Release Date : 2011-01-25

Design And Analysis Of Clinical Experiments written by Joseph L. Fleiss 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 2011-01-25 with Mathematics categories.


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.



Sequential Medical Trials For Comparing An Experimental With A Standard Treatment


Sequential Medical Trials For Comparing An Experimental With A Standard Treatment
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Author : A. John Petkau
language : en
Publisher:
Release Date : 1975

Sequential Medical Trials For Comparing An Experimental With A Standard Treatment written by A. John Petkau and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1975 with Brownian motion processes categories.


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.



Translational And Experimental Clinical Research


Translational And Experimental Clinical Research
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Author : Daniel P. Schuster
language : en
Publisher: Lippincott Williams & Wilkins
Release Date : 2005

Translational And Experimental Clinical Research written by Daniel P. Schuster and has been published by Lippincott Williams & Wilkins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Medical categories.


This volume is a comprehensive textbook for investigators entering the rapidly growing field of translational and experimental clinical research. The book offers detailed guidelines for designing and conducting a study and analyzing and reporting results and discusses key ethical and regulatory issues. Chapters address specific types of studies such as clinical experiments in small numbers of patients, pharmacokinetics and pharmacodynamics, and gene therapy and pharmacogenomic studies. A major section describes modern techniques of translational clinical research, including gene expression, identifying mutations and polymorphisms, cloning, transcriptional profiling, proteomics, cell and tissue imaging, tissue banking, evaluating substrate metabolism, and in vivo imaging.



Group Sequential And Confirmatory Adaptive Designs In Clinical Trials


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.