Some Group Sequential Testing Methods In Clinical Trials

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Group Sequential Methods with Applications to Clinical Trials

Author : Christopher Jennison
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.

Sequential Experimentation in Clinical Trials

Author : Jay Bartroff
Publisher : Springer Science & Business Media
ISBN 13 : 1461461146
Total Pages : 250 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Sequential Experimentation in Clinical Trials by : Jay Bartroff

Download or read book Sequential Experimentation in Clinical Trials written by Jay Bartroff and published by Springer Science & Business Media. This book was released on 2012-12-12 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Gernot Wassmer
Publisher : Springer
ISBN 13 : 3319325620
Total Pages : 310 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Group Sequential and Confirmatory Adaptive Designs in Clinical Trials by : Gernot Wassmer

Download or read book Group Sequential and Confirmatory Adaptive Designs in Clinical Trials written by Gernot Wassmer and published by Springer. This book was released on 2016-07-04 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 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 221 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.

Some Group Sequential Testing Methods in Clinical Trials

Author : Huaibao Feng
Publisher :
ISBN 13 :
Total Pages : 134 pages
Book Rating : 4.:/5 (89 download)

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Book Synopsis Some Group Sequential Testing Methods in Clinical Trials by : Huaibao Feng

Download or read book Some Group Sequential Testing Methods in Clinical Trials written by Huaibao Feng and published by . This book was released on 2008 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Adaptive Design Methods in Clinical Trials

Author : Shein-Chung Chow
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

Principles and Practice of Clinical Trials

Author : Steven Piantadosi
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Recent Advances in Clinical Trial Design and Analysis

Author : Peter F. Thall
Publisher : Springer Science & Business Media
ISBN 13 : 1461520096
Total Pages : 263 pages
Book Rating : 4.4/5 (615 download)

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Book Synopsis Recent Advances in Clinical Trial Design and Analysis by : Peter F. Thall

Download or read book Recent Advances in Clinical Trial Design and Analysis written by Peter F. Thall and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.

Modern Approaches to Clinical Trials Using SAS

Author : Sandeep Menon
Publisher : SAS Institute
ISBN 13 : 1629600822
Total Pages : 496 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 496 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.

The Design and Analysis of Sequential Clinical Trials

Author : John Whitehead
Publisher : Horwood Publishing Limited
ISBN 13 :
Total Pages : 280 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Design and Analysis of Sequential Clinical Trials by : John Whitehead

Download or read book The Design and Analysis of Sequential Clinical Trials written by John Whitehead and published by Horwood Publishing Limited. This book was released on 1983 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sequential statistics

Author : Z. Govindarajulu
Publisher : World Scientific
ISBN 13 : 9789812389053
Total Pages : 338 pages
Book Rating : 4.3/5 (89 download)

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Book Synopsis Sequential statistics by : Z. Govindarajulu

Download or read book Sequential statistics written by Z. Govindarajulu and published by World Scientific. This book was released on 2004 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains topics that can be covered in a single-semester course. Only elementary proofs are provided, and thus the mathematics and statistics are maintained at a basic level. Only a course in each of three areas ? advanced calculus, probability and statistical inference ? is assumed of the student. The book has a chapter on applications to biostatistics and a supplement presenting computer programs for selected sequential procedures. Identified problems are provided at the end of each chapter.

Randomization in Clinical Trials

Author : William F. Rosenberger
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.

Clinical Trials

Author : Stuart J. Pocock
Publisher : John Wiley & Sons
ISBN 13 : 1118794109
Total Pages : 228 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Clinical Trials by : Stuart J. Pocock

Download or read book Clinical Trials written by Stuart J. Pocock and published by John Wiley & Sons. This book was released on 2013-07-17 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Introduction to Statistical Methods for Clinical Trials

Author : Thomas D. Cook
Publisher : CRC Press
ISBN 13 : 1584880279
Total Pages : 465 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Introduction to Statistical Methods for Clinical Trials by : Thomas D. Cook

Download or read book Introduction to Statistical Methods for Clinical Trials written by Thomas D. Cook and published by CRC Press. This book was released on 2007-11-19 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sequential Analysis

Author : David Siegmund
Publisher : Springer Science & Business Media
ISBN 13 : 1475718624
Total Pages : 285 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Sequential Analysis by : David Siegmund

Download or read book Sequential Analysis written by David Siegmund and published by Springer Science & Business Media. This book was released on 2013-04-09 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: The modern theory of Sequential Analysis came into existence simultaneously in the United States and Great Britain in response to demands for more efficient sampling inspection procedures during World War II. The develop ments were admirably summarized by their principal architect, A. Wald, in his book Sequential Analysis (1947). In spite of the extraordinary accomplishments of this period, there remained some dissatisfaction with the sequential probability ratio test and Wald's analysis of it. (i) The open-ended continuation region with the concomitant possibility of taking an arbitrarily large number of observations seems intol erable in practice. (ii) Wald's elegant approximations based on "neglecting the excess" of the log likelihood ratio over the stopping boundaries are not especially accurate and do not allow one to study the effect oftaking observa tions in groups rather than one at a time. (iii) The beautiful optimality property of the sequential probability ratio test applies only to the artificial problem of testing a simple hypothesis against a simple alternative. In response to these issues and to new motivation from the direction of controlled clinical trials numerous modifications of the sequential probability ratio test were proposed and their properties studied-often by simulation or lengthy numerical computation. (A notable exception is Anderson, 1960; see III.7.) In the past decade it has become possible to give a more complete theoretical analysis of many of the proposals and hence to understand them better.

Encyclopedia of Research Design

Author : Neil J. Salkind
Publisher : SAGE
ISBN 13 : 1412961270
Total Pages : 1779 pages
Book Rating : 4.4/5 (129 download)

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Book Synopsis Encyclopedia of Research Design by : Neil J. Salkind

Download or read book Encyclopedia of Research Design written by Neil J. Salkind and published by SAGE. This book was released on 2010-06-22 with total page 1779 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Comprising more than 500 entries, the Encyclopedia of Research Design explains how to make decisions about research design, undertake research projects in an ethical manner, interpret and draw valid inferences from data, and evaluate experiment design strategies and results. Two additional features carry this encyclopedia far above other works in the field: bibliographic entries devoted to significant articles in the history of research design and reviews of contemporary tools, such as software and statistical procedures, used to analyze results. It covers the spectrum of research design strategies, from material presented in introductory classes to topics necessary in graduate research; it addresses cross- and multidisciplinary research needs, with many examples drawn from the social and behavioral sciences, neurosciences, and biomedical and life sciences; it provides summaries of advantages and disadvantages of often-used strategies; and it uses hundreds of sample tables, figures, and equations based on real-life cases."--Publisher's description.

Analysis of Clinical Trials Using SAS

Author : Alex Dmitrienko
Publisher : SAS Institute
ISBN 13 : 1635261449
Total Pages : 455 pages
Book Rating : 4.6/5 (352 download)

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Book Synopsis Analysis of Clinical Trials Using SAS by : Alex Dmitrienko

Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.