Flexible Group Sequential Designs For Clinical Trials

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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.

Flexible Group Sequential Designs for Clinical Trials

Author : Yonghua Chen
Publisher :
ISBN 13 :
Total Pages : 212 pages
Book Rating : 4.:/5 (89 download)

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Book Synopsis Flexible Group Sequential Designs for Clinical Trials by : Yonghua Chen

Download or read book Flexible Group Sequential Designs for Clinical Trials written by Yonghua Chen and published by . This book was released on 2000 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

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

Adaptive and Flexible Clinical Trials

Author : Richard Chin
Publisher : CRC Press
ISBN 13 : 143983833X
Total Pages : 189 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Adaptive and Flexible Clinical Trials by : Richard Chin

Download or read book Adaptive and Flexible Clinical Trials written by Richard Chin and published by CRC Press. This book was released on 2016-04-19 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistic

Group-Sequential Clinical Trials with Multiple Co-Objectives

Author : Toshimitsu Hamasaki
Publisher : Springer
ISBN 13 : 4431559000
Total Pages : 118 pages
Book Rating : 4.4/5 (315 download)

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Book Synopsis Group-Sequential Clinical Trials with Multiple Co-Objectives by : Toshimitsu Hamasaki

Download or read book Group-Sequential Clinical Trials with Multiple Co-Objectives written by Toshimitsu Hamasaki and published by Springer. This book was released on 2016-06-01 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternative hypothesis (stopping for either futility or efficacy), where the trial is designed to evaluate whether the intervention is superior to the control on all endpoints. For assessing futility, there are two fundamental approaches, i.e., the decision to stop for futility based on the conditional probability of rejecting the null hypothesis, and the other based on stopping boundaries using group sequential methods. In this book, the latter approach is discussed. The book also briefly deals with the group sequential methods for clinical trials designed to evaluate whether the intervention is superior to the control on at least one endpoint. In addition, the book describes sample size recalculation and the resulting effect on power and type I error rate. The book also describes group sequential strategies for three-arm clinical trials to demonstrate the non-inferiority of experimental intervention to actively control and to assess the assay sensitivity to placebo control.

Adaptive Design Methods in Clinical Trials

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 158488777X
Total Pages : 296 pages
Book Rating : 4.5/5 (848 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 2006-11-16 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures

More Flexible Sequential and Non-sequential Designs in Long-term Clinical Trials

Author : K. K. Gordon Lan
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.:/5 (187 download)

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Book Synopsis More Flexible Sequential and Non-sequential Designs in Long-term Clinical Trials by : K. K. Gordon Lan

Download or read book More Flexible Sequential and Non-sequential Designs in Long-term Clinical Trials written by K. K. Gordon Lan and published by . This book was released on 1984 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Designs for Clinical Trials

Author : David Harrington
Publisher : Springer Science & Business Media
ISBN 13 : 1461401402
Total Pages : 213 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Designs for Clinical Trials by : David Harrington

Download or read book Designs for Clinical Trials written by David Harrington and published by Springer Science & Business Media. This book was released on 2011-10-09 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

The Design and Analysis of Sequential Clinical Trials

Author : John Whitehead
Publisher : John Wiley & Sons
ISBN 13 : 9780471975502
Total Pages : 342 pages
Book Rating : 4.9/5 (755 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 John Wiley & Sons. This book was released on 1997-08-04 with total page 342 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. Emphasis is placed on the triangular test and other procedures based on straight line stopping boundaries. These methods allow for frequent or occasional interim analyses and permit the analysis of a wide variety of patient responses. Alternative procedures are also covered in detail, and these include -spending function methods, repeated confidence intervals and Bayesian approaches to sequential clinical trials.

Targeted Therapies

Author : Baldur Páll Magnússon
Publisher :
ISBN 13 :
Total Pages : 452 pages
Book Rating : 4.:/5 (798 download)

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Book Synopsis Targeted Therapies by : Baldur Páll Magnússon

Download or read book Targeted Therapies written by Baldur Páll Magnússon and published by . This book was released on 2011 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: A critical part of clinical trials in drug development is the analysis of treatment efficacy in patient subgroups (subpopulations). Due to multiplicity and the small sample sizes involved, this analysis presents substantial statistical challenges and can lead to misleading conclusions. In this thesis, we develop methodology for statistically valid subgroup analysis in a variety of settings. First, we consider a number of trial designs of varying flexibility for the case of one subgroup of interest. Some procedures are novel, while others are adapted from the literature. Included is data-driven consideration of adaptive change of subject eligibility criteria-known as adaptive enrichment-whereby apparently nonresponsive patient populations are not recruited after data has been unblinded for an interim analysis. We conduct an extensive numerical study to investigate design operating characteristics, as well as sensitivity to subgroup prevalence and interim analysis timing. We observe that power gains can be substantial when a treatment is only effective in the subgroup of interest. Following this example, selected procedures are generalized to allow for analysis of an arbitrary number of subgroups. Next, we propose a K -stage group sequential design that can be applied as a confirmatory seamless Phase II/III design. The design is specified through upper and lower spending functions, defined in terms of calendar times. After the first stage, poorly performing subgroups are eliminated and the remaining population is pooled for the duration of the trial. This procedure combines the elimination of non-sensitive subgroups with the definitive assessment of treatment efficacy associated with traditional group sequential designs. Numerical examples show that the procedure has high power to detect subgroup-specific effects, and the use of multiple interim analysis points can lead to substantial sample size savings. We address the challenges of adjusting for selection bias, and protecting the familywise error rate in the strong sense. All designs are presented either in terms of standardized test statistics or the efficient score, making the analysis of normal, binary, or time-to-event data straightforward.

Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

Author : Mark Chang
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.

Practical Considerations for Adaptive Trial Design and Implementation

Author : Weili He
Publisher : Springer
ISBN 13 : 1493911007
Total Pages : 420 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 420 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.

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.

A Comparison of Adaptive Designs in Clinical Trials

Author : Sukyung Park
Publisher :
ISBN 13 :
Total Pages : 112 pages
Book Rating : 4.:/5 (892 download)

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Book Synopsis A Comparison of Adaptive Designs in Clinical Trials by : Sukyung Park

Download or read book A Comparison of Adaptive Designs in Clinical Trials written by Sukyung Park and published by . This book was released on 2014 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent times, there has been an increasing interest in adaptive designs for clinical trials. As opposed to conventional designs, adaptive designs allow flexible design adaptation in the middle of a trial based on accumulated data. Although various models have been developed using both frequentist and Bayesian perspectives, relative statistical performances of adaptive designs are somewhat controversial and little is known about those of Bayesian adaptive designs. Most comparison studies also focused on single experimental treatment rather than multiple experimental treatments. In this report, both frequentist and Baysian adaptive designs were compared in terms of statistical power by a simulation study, assuming the situation when multiple experimental treatments are tested in multiple stages. The designs included in the current study are group sequential design (frequentist), adaptive design based on combination tests (frequentist), and Bayesian adaptive design (Bayesian). Based upon the results under multiple scenarios, the Bayesian adaptive design showed the highest power, and the design based on combination tests performed better than group sequential designs when proper interim adaptation could be conducted to increase power.

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.