Some Group Sequential Testing Methods In Clinical Trials
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Group Sequential Methods With Applications To Clinical Trials
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Author : Christopher Jennison
language : en
Publisher: CRC Press
Release Date : 1999-09-15
Group Sequential Methods With Applications To Clinical Trials written by Christopher Jennison and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-09-15 with Mathematics 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.
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.
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.
Some Group Sequential Testing Methods In Clinical Trials
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Author : Huaibao Feng
language : en
Publisher:
Release Date : 2008
Some Group Sequential Testing Methods In Clinical Trials written by Huaibao Feng and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.
Modern Approaches To Clinical Trials Using Sas Classical Adaptive And Bayesian Methods
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Author : Sandeep Menon
language : en
Publisher: SAS Institute
Release Date : 2015-12-09
Modern Approaches To Clinical Trials Using Sas Classical Adaptive And Bayesian Methods written by Sandeep Menon and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-12-09 with Computers categories.
This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and 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, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. --
Introduction To Statistical Methods For Clinical Trials
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Author : Thomas D. Cook
language : en
Publisher: CRC Press
Release Date : 2007-11-19
Introduction To Statistical Methods For Clinical Trials written by Thomas D. Cook and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-19 with Mathematics categories.
Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.
Clinical Trials
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Author : Steven Piantadosi
language : en
Publisher: John Wiley & Sons
Release Date : 2024-04-03
Clinical Trials written by Steven Piantadosi 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 2024-04-03 with Mathematics categories.
Clinical Trials Comprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials The Fourth Edition of Clinical Trials builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results. Each chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge. Written by a highly qualified author with significant experience in the field, the Fourth Edition of Clinical Trials approaches the topic with: Problems that may arise during a trial, and accompanying common sense solutions Design alternatives for addressing many questions in therapeutic development Statistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and more Alternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care data Revamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures Standing out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, Clinical Trials is an essential learning aid on the subject for undergraduate and graduate clinical trials courses.
Methods And Applications Of Statistics In Clinical Trials Volume 1
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Author : Narayanaswamy Balakrishnan
language : en
Publisher: John Wiley & Sons
Release Date : 2014-03-05
Methods And Applications Of Statistics In Clinical Trials Volume 1 written by Narayanaswamy Balakrishnan 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 2014-03-05 with Medical categories.
A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.
Handbook Of Sequential Analysis
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Author : B.K. Ghosh
language : en
Publisher: CRC Press
Release Date : 1991-04-24
Handbook Of Sequential Analysis written by B.K. Ghosh and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991-04-24 with Mathematics categories.
Sequential analysis refers to the body of statistical theory and methods where the sample size may depend in a random manner on the accumulating data. A formal theory in which optimal tests are derived for simple statistical hypotheses in such a framework was developed by Abraham Wald in the early 1
Planning And Analyzing Clinical Trials With Composite Endpoints
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Author : Geraldine Rauch
language : en
Publisher: Springer
Release Date : 2018-05-22
Planning And Analyzing Clinical Trials With Composite Endpoints written by Geraldine Rauch and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-22 with Medical categories.
This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.