Randomised Response-Adaptive Designs in Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1584886935
Total Pages : 341 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Randomised Response-Adaptive Designs in Clinical Trials by : Anthony C Atkinson

Download or read book Randomised Response-Adaptive Designs in Clinical Trials written by Anthony C Atkinson and published by CRC Press. This book was released on 2013-12-26 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Randomised Response-Adaptive Designs in Clinical Trials

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Author :
Publisher : CRC Press
ISBN 13 : 1584886943
Total Pages : 339 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Randomised Response-Adaptive Designs in Clinical Trials by : Anthony C Atkinson

Download or read book Randomised Response-Adaptive Designs in Clinical Trials written by Anthony C Atkinson and published by CRC Press. This book was released on 2013-12-26 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Theory of Response-Adaptive Randomization in Clinical Trials

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470055871
Total Pages : 234 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis The Theory of Response-Adaptive Randomization in Clinical Trials by : Feifang Hu

Download or read book The Theory of Response-Adaptive Randomization in Clinical Trials written by Feifang Hu and published by John Wiley & Sons. This book was released on 2006-09-29 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents a firm mathematical basis for the use of response-adaptive randomization procedures in practice The Theory of Response-Adaptive Randomization in Clinical Trials is the result of the authors' ten-year collaboration as well as their collaborations with other researchers in investigating the important questions regarding response-adaptive randomization in a rigorous mathematical framework. Response-adaptive allocation has a long history in biostatistics literature; however, largely due to the disastrous ECMO trial in the early 1980s, there is a general reluctance to use these procedures. This timely book represents a mathematically rigorous subdiscipline of experimental design involving randomization and answers fundamental questions, including: How does response-adaptive randomization affect power? Can standard inferential tests be applied following response-adaptive randomization? What is the effect of delayed response? Which procedure is most appropriate and how can "most appropriate" be quantified? How can heterogeneity of the patient population be incorporated? Can response-adaptive randomization be performed with more than two treatments or with continuous responses? The answers to these questions communicate a thorough understanding of the asymptotic properties of each procedure discussed, including asymptotic normality, consistency, and asymptotic variance of the induced allocation. Topical coverage includes: The relationship between power and response-adaptive randomization The general result for determining asymptotically best procedures Procedures based on urn models Procedures based on sequential estimation Implications for the practice of clinical trials Useful for graduate students in mathematics, statistics, and biostatistics as well as researchers and industrial and academic biostatisticians, this book offers a rigorous treatment of the subject in order to find the optimal procedure to use in practice.

Modern Adaptive Randomized Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1482239892
Total Pages : 536 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Modern Adaptive Randomized Clinical Trials by : Oleksandr Sverdlov

Download or read book Modern Adaptive Randomized Clinical Trials written by Oleksandr Sverdlov and published by CRC Press. This book was released on 2015-06-30 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive random

Randomization in Clinical Trials

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118742249
Total Pages : 284 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book…” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

Adaptive Design Methods in Clinical Trials

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Author :
Publisher : CRC Press
ISBN 13 : 1439839883
Total Pages : 368 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Adaptive Design Methods in Clinical Trials by : Shein-Chung Chow

Download or read book Adaptive Design Methods in Clinical Trials written by Shein-Chung Chow and published by CRC Press. This book was released on 2011-12-01 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Practical Considerations for Adaptive Trial Design and Implementation

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Publisher : Springer
ISBN 13 : 1493911007
Total Pages : 416 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Practical Considerations for Adaptive Trial Design and Implementation by : Weili He

Download or read book Practical Considerations for Adaptive Trial Design and Implementation written by Weili He and published by Springer. This book was released on 2014-10-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470438568
Total Pages : 284 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio by : Mark Chang

Download or read book Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio written by Mark Chang and published by John Wiley & Sons. This book was released on 2010-06-15 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Bayesian Adaptive Methods for Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1439825513
Total Pages : 316 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Bayesian Adaptive Methods for Clinical Trials by : Scott M. Berry

Download or read book Bayesian Adaptive Methods for Clinical Trials written by Scott M. Berry and published by CRC Press. This book was released on 2010-07-19 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Small Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 9780309171144
Total Pages : 222 pages
Book Rating : 4.1/5 (711 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

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Author :
Publisher : CRC Press
ISBN 13 : 9781439810170
Total Pages : 496 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Handbook of Adaptive Designs in Pharmaceutical and Clinical Development by : Annpey Pong

Download or read book Handbook of Adaptive Designs in Pharmaceutical and Clinical Development written by Annpey Pong and published by CRC Press. This book was released on 2016-04-19 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Clinical Trial Design Challenges in Mood Disorders

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Publisher : Academic Press
ISBN 13 : 0124051766
Total Pages : 192 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Clinical Trial Design Challenges in Mood Disorders by : Mauricio Tohen

Download or read book Clinical Trial Design Challenges in Mood Disorders written by Mauricio Tohen and published by Academic Press. This book was released on 2015-01-24 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. Summarizes common trial design problems and their solutions Encompasses funding, subject selection, regulatory issues and more Identifies best practices for definitive and generalizable results Includes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups

Introduction to Adaptive Trial Designs and Master Protocols

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Publisher : Cambridge University Press
ISBN 13 : 1108926983
Total Pages : 189 pages
Book Rating : 4.1/5 (89 download)

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Book Synopsis Introduction to Adaptive Trial Designs and Master Protocols by : Jay J. H. Park

Download or read book Introduction to Adaptive Trial Designs and Master Protocols written by Jay J. H. Park and published by Cambridge University Press. This book was released on 2023-03-31 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique and practical high-level introductory guide to the emerging field of adaptive trial designs, platform trials, and master protocols.

Modern Approaches to Clinical Trials Using SAS

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Author :
Publisher : SAS Institute
ISBN 13 : 1629600822
Total Pages : 482 pages
Book Rating : 4.6/5 (296 download)

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Book Synopsis Modern Approaches to Clinical Trials Using SAS by : Sandeep Menon

Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.

Randomization in Clinical Trials

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Publisher : John Wiley & Sons
ISBN 13 : 0471654078
Total Pages : 286 pages
Book Rating : 4.4/5 (716 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2004-03-24 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique overview that melds the concepts of conditionalprobability and stochastic processes into real-lifeapplications The role of randomization techniques in clinical trials has becomeincreasingly important. This comprehensive guide combines both theapplied aspects of randomization in clinical trials with aprobabilistic treatment of properties of randomization. Taking anunabashedly non-Bayesian and nonparametric approach to inference,the book focuses on the linear rank test under a randomizationmodel, with added discussion on likelihood-based inference as itrelates to sufficiency and ancillarity. Developments in stochasticprocesses and applied probability are also given where appropriate.Intuition is stressed over mathematics, but not without a cleardevelopment of the latter in the context of the former. Providing a consolidated review of the field, the book includesrelevant and practical discussions of: * The benefits of randomization in terms of reduction of bias * Randomization as a basis for inference * Covariate-adaptive and response-adaptive randomization * Current philosophies, controversies, and new developments With ample problem sets, theoretical exercises, and short computersimulations using SAS, Randomization in Clinical Trials: Theory andPractice is equally useful as a standard textbook in biostatisticsgraduate programs as well as a reliable reference forbiostatisticians in practice.

Group Sequential Methods with Applications to Clinical Trials

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Author :
Publisher : CRC Press
ISBN 13 : 9781584888581
Total Pages : 416 pages
Book Rating : 4.8/5 (885 download)

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Book Synopsis Group Sequential Methods with Applications to Clinical Trials by : Christopher Jennison

Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Applied Advanced Analytics

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Author :
Publisher : Springer Nature
ISBN 13 : 9813366567
Total Pages : 236 pages
Book Rating : 4.8/5 (133 download)

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Book Synopsis Applied Advanced Analytics by : Arnab Kumar Laha

Download or read book Applied Advanced Analytics written by Arnab Kumar Laha and published by Springer Nature. This book was released on 2021-06-08 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers several new areas in the growing field of analytics with some innovative applications in different business contexts, and consists of selected presentations at the 6th IIMA International Conference on Advanced Data Analysis, Business Analytics and Intelligence. The book is conceptually divided in seven parts. The first part gives expository briefs on some topics of current academic and practitioner interests, such as data streams, binary prediction and reliability shock models. In the second part, the contributions look at artificial intelligence applications with chapters related to explainable AI, personalized search and recommendation, and customer retention management. The third part deals with credit risk analytics, with chapters on optimization of credit limits and mitigation of agricultural lending risks. In its fourth part, the book explores analytics and data mining in the retail context. In the fifth part, the book presents some applications of analytics to operations management. This part has chapters related to improvement of furnace operations, forecasting food indices and analytics for improving student learning outcomes. The sixth part has contributions related to adaptive designs in clinical trials, stochastic comparisons of systems with heterogeneous components and stacking of models. The seventh and final part contains chapters related to finance and economics topics, such as role of infrastructure and taxation on economic growth of countries and connectedness of markets with heterogenous agents, The different themes ensure that the book would be of great value to practitioners, post-graduate students, research scholars and faculty teaching advanced business analytics courses.