Group Sequential Clinical Trials With Multiple Co Objectives

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Group-Sequential Clinical Trials with Multiple Co-Objectives

Toshimitsu Hamasaki,Koko Asakura,Scott R. Evans,Toshimitsu Ochiai
Group Sequential Clinical Trials with Multiple Co Objectives Book PDF

Author : Toshimitsu Hamasaki,Koko Asakura,Scott R. Evans,Toshimitsu Ochiai
Publisher : Springer
Page : 113 pages
File Size : 53,7 Mb
Release : 2016-06-01
Category : Mathematics
ISBN : 9784431559009

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Group-Sequential Clinical Trials with Multiple Co-Objectives by Toshimitsu Hamasaki,Koko Asakura,Scott R. Evans,Toshimitsu Ochiai Pdf

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.

Group Sequential Methods with Applications to Clinical Trials

Christopher Jennison
Group Sequential Methods with Applications to Clinical Trials Book PDF

Author : Christopher Jennison
Publisher : Unknown
Page : 390 pages
File Size : 42,8 Mb
Release : 2000
Category : MEDICAL
ISBN : 0367805324

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Group Sequential Methods with Applications to Clinical Trials by Christopher Jennison Pdf

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.

Sample Size Determination in Clinical Trials with Multiple Endpoints

Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans
Sample Size Determination in Clinical Trials with Multiple Endpoints Book PDF

Author : Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans
Publisher : Springer
Page : 95 pages
File Size : 54,6 Mb
Release : 2015-08-20
Category : Mathematics
ISBN : 9783319220055

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Sample Size Determination in Clinical Trials with Multiple Endpoints by Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans Pdf

This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.

Survival Analysis with Correlated Endpoints

Takeshi Emura,Shigeyuki Matsui,Virginie Rondeau
Survival Analysis with Correlated Endpoints Book PDF

Author : Takeshi Emura,Shigeyuki Matsui,Virginie Rondeau
Publisher : Springer
Page : 118 pages
File Size : 50,7 Mb
Release : 2019-03-25
Category : Medical
ISBN : 9789811335167

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Survival Analysis with Correlated Endpoints by Takeshi Emura,Shigeyuki Matsui,Virginie Rondeau Pdf

This book introduces readers to advanced statistical methods for analyzing survival data involving correlated endpoints. In particular, it describes statistical methods for applying Cox regression to two correlated endpoints by accounting for dependence between the endpoints with the aid of copulas. The practical advantages of employing copula-based models in medical research are explained on the basis of case studies. In addition, the book focuses on clustered survival data, especially data arising from meta-analysis and multicenter analysis. Consequently, the statistical approaches presented here employ a frailty term for heterogeneity modeling. This brings the joint frailty-copula model, which incorporates a frailty term and a copula, into a statistical model. The book also discusses advanced techniques for dealing with high-dimensional gene expressions and developing personalized dynamic prediction tools under the joint frailty-copula model. To help readers apply the statistical methods to real-world data, the book provides case studies using the authors’ original R software package (freely available in CRAN). The emphasis is on clinical survival data, involving time-to-tumor progression and overall survival, collected on cancer patients. Hence, the book offers an essential reference guide for medical statisticians and provides researchers with advanced, innovative statistical tools. The book also provides a concise introduction to basic multivariate survival models.

The Design and Analysis of Sequential Clinical Trials

John Whitehead
The Design and Analysis of Sequential Clinical Trials Book PDF

Author : John Whitehead
Publisher : Horwood Publishing Limited
Page : 280 pages
File Size : 46,9 Mb
Release : 1983
Category : Health & Fitness
ISBN : UOM:39015015600102

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The Design and Analysis of Sequential Clinical Trials by John Whitehead Pdf

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.

Group Sequential Methods with Applications to Clinical Trials

Christopher Jennison,Bruce W. Turnbull
Group Sequential Methods with Applications to Clinical Trials Book PDF

Author : Christopher Jennison,Bruce W. Turnbull
Publisher : CRC Press
Page : 416 pages
File Size : 45,5 Mb
Release : 1999-09-15
Category : Mathematics
ISBN : 158488858X

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Group Sequential Methods with Applications to Clinical Trials by Christopher Jennison,Bruce W. Turnbull Pdf

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.

Modern Approaches to Clinical Trials Using SAS

Sandeep Menon,Richard C. Zink
Modern Approaches to Clinical Trials Using SAS Book PDF

Author : Sandeep Menon,Richard C. Zink
Publisher : SAS Institute
Page : 482 pages
File Size : 47,9 Mb
Release : 2015-12-09
Category : Computers
ISBN : 9781629600826

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Modern Approaches to Clinical Trials Using SAS by Sandeep Menon,Richard C. Zink Pdf

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.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 426 pages
File Size : 55,8 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9789811078200

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep Menon Pdf

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Multiple Testing Problems in Pharmaceutical Statistics

Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz
Multiple Testing Problems in Pharmaceutical Statistics Book PDF

Author : Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz
Publisher : CRC Press
Page : 323 pages
File Size : 40,6 Mb
Release : 2009-12-08
Category : Mathematics
ISBN : 9781584889854

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Multiple Testing Problems in Pharmaceutical Statistics by Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz Pdf

Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c

Sample Size Determination in Clinical Trials with Multiple Endpoints

Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans
Sample Size Determination in Clinical Trials with Multiple Endpoints Book PDF

Author : Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans
Publisher : Unknown
Page : 128 pages
File Size : 46,6 Mb
Release : 2015
Category : Electronic
ISBN : 3319220063

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Sample Size Determination in Clinical Trials with Multiple Endpoints by Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans Pdf

This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints. .

Sequential Experimentation in Clinical Trials

Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih
Sequential Experimentation in Clinical Trials Book PDF

Author : Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih
Publisher : Springer Science & Business Media
Page : 250 pages
File Size : 40,5 Mb
Release : 2012-12-12
Category : Medical
ISBN : 9781461461142

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Sequential Experimentation in Clinical Trials by Jay Bartroff,Tze Leung Lai,Mei-Chiung Shih Pdf

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

Gernot Wassmer,Werner Brannath
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials Book PDF

Author : Gernot Wassmer,Werner Brannath
Publisher : Springer
Page : 301 pages
File Size : 43,8 Mb
Release : 2016-07-04
Category : Medical
ISBN : 9783319325620

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Group Sequential and Confirmatory Adaptive Designs in Clinical Trials by Gernot Wassmer,Werner Brannath Pdf

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.

Practical Considerations for Adaptive Trial Design and Implementation

Weili He,José Pinheiro,Olga M. Kuznetsova
Practical Considerations for Adaptive Trial Design and Implementation Book PDF

Author : Weili He,José Pinheiro,Olga M. Kuznetsova
Publisher : Springer
Page : 416 pages
File Size : 52,8 Mb
Release : 2014-10-15
Category : Medical
ISBN : 9781493911004

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Practical Considerations for Adaptive Trial Design and Implementation by Weili He,José Pinheiro,Olga M. Kuznetsova Pdf

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.

Applied Statistics in Biomedicine and Clinical Trials Design

Zhen Chen,Aiyi Liu,Yongming Qu,Larry Tang,Naitee Ting,Yi Tsong
Applied Statistics in Biomedicine and Clinical Trials Design Book PDF

Author : Zhen Chen,Aiyi Liu,Yongming Qu,Larry Tang,Naitee Ting,Yi Tsong
Publisher : Springer
Page : 546 pages
File Size : 47,8 Mb
Release : 2015-05-04
Category : Medical
ISBN : 9783319126944

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Applied Statistics in Biomedicine and Clinical Trials Design by Zhen Chen,Aiyi Liu,Yongming Qu,Larry Tang,Naitee Ting,Yi Tsong Pdf

This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

Oncology Clinical Trials

Susan Halabi, PhD,Wm. Kevin Kelly, DO
Oncology Clinical Trials Book PDF

Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
Publisher : Demos Medical Publishing
Page : 168 pages
File Size : 43,5 Mb
Release : 2009-12-22
Category : Medical
ISBN : 1935281763

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Oncology Clinical Trials by Susan Halabi, PhD,Wm. Kevin Kelly, DO Pdf

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout