Statistical Methods For Survival Trial Design

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Statistical Methods for Survival Trial Design

Author : Jianrong Wu
Publisher : CRC Press
ISBN 13 : 0429892934
Total Pages : 243 pages
Book Rating : 4.4/5 (298 download)

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Book Synopsis Statistical Methods for Survival Trial Design by : Jianrong Wu

Download or read book Statistical Methods for Survival Trial Design written by Jianrong Wu and published by CRC Press. This book was released on 2018-06-14 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

Statistical Methods for Survival Trial Design

Author : Jianrong Wu
Publisher : CRC Press
ISBN 13 : 0429892942
Total Pages : 257 pages
Book Rating : 4.4/5 (298 download)

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Book Synopsis Statistical Methods for Survival Trial Design by : Jianrong Wu

Download or read book Statistical Methods for Survival Trial Design written by Jianrong Wu and published by CRC Press. This book was released on 2018-06-14 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

Single-Arm Phase II Survival Trial Design

Author : Jianrong Wu
Publisher : CRC Press
ISBN 13 : 1000421732
Total Pages : 273 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Single-Arm Phase II Survival Trial Design by : Jianrong Wu

Download or read book Single-Arm Phase II Survival Trial Design written by Jianrong Wu and published by CRC Press. This book was released on 2021-07-19 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.

Statistical Methods for Survival Data Analysis

Author : Elisa T. Lee
Publisher : John Wiley & Sons
ISBN 13 : 1118593057
Total Pages : 512 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Statistical Methods for Survival Data Analysis by : Elisa T. Lee

Download or read book Statistical Methods for Survival Data Analysis written by Elisa T. Lee and published by John Wiley & Sons. This book was released on 2013-09-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Third Edition “. . . an easy-to read introduction to survival analysiswhich covers the major concepts and techniques of thesubject.” —Statistics in Medical Research Updated and expanded to reflect the latest developments,Statistical Methods for Survival Data Analysis, FourthEdition continues to deliver a comprehensive introduction tothe most commonly-used methods for analyzing survival data.Authored by a uniquely well-qualified author team, the FourthEdition is a critically acclaimed guide to statistical methods withapplications in clinical trials, epidemiology, areas of business,and the social sciences. The book features many real-world examplesto illustrate applications within these various fields, althoughspecial consideration is given to the study of survival data inbiomedical sciences. Emphasizing the latest research and providing the mostup-to-date information regarding software applications in thefield, Statistical Methods for Survival Data Analysis, FourthEdition also includes: Marginal and random effect models for analyzing correlatedcensored or uncensored data Multiple types of two-sample and K-sample comparisonanalysis Updated treatment of parametric methods for regression modelfitting with a new focus on accelerated failure time models Expanded coverage of the Cox proportional hazards model Exercises at the end of each chapter to deepen knowledge of thepresented material Statistical Methods for Survival Data Analysis is anideal text for upper-undergraduate and graduate-level courses onsurvival data analysis. The book is also an excellent resource forbiomedical investigators, statisticians, and epidemiologists, aswell as researchers in every field in which the analysis ofsurvival data plays a role.

Statistical Methods for Survival Data Analysis

Author : Elisa T. Lee
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 504 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Statistical Methods for Survival Data Analysis by : Elisa T. Lee

Download or read book Statistical Methods for Survival Data Analysis written by Elisa T. Lee and published by Wiley-Interscience. This book was released on 1992-05-07 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Functions of survival time; Examples of survival data analysis; Nonparametric methods of estimating survival functions; Nonparametric methods for comparing survival distributions; Some well-known survival distributions and their applications; Graphical methods for sulvival distribution fitting and goodness-of-fit tests; Analytical estimation procedures for sulvival distributions; Parametric methods for comparing two survival distribution; Identification of prognostic factors related to survival time; Identification of risk factors related to dichotomous data; Planning and design of clinical trials (I); Planning and design of clinicL trials(II).

Single-Arm Phase II Survival Trial Design

Author : Jianrong Wu
Publisher : CRC Press
ISBN 13 : 1000422488
Total Pages : 225 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Single-Arm Phase II Survival Trial Design by : Jianrong Wu

Download or read book Single-Arm Phase II Survival Trial Design written by Jianrong Wu and published by CRC Press. This book was released on 2021-08-06 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.

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.

Small Clinical Trials

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

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Book Synopsis Small Clinical Trials by : Institute of Medicine

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

Statistical Design, Monitoring, and Analysis of Clinical Trials

Author : Weichung Joe Shih
Publisher : CRC Press
ISBN 13 : 1000462757
Total Pages : 405 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Statistical Design, Monitoring, and Analysis of Clinical Trials by : Weichung Joe Shih

Download or read book Statistical Design, Monitoring, and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2021-10-25 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Handbook of Survival Analysis

Author : John P. Klein
Publisher : CRC Press
ISBN 13 : 146655567X
Total Pages : 635 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Handbook of Survival Analysis by : John P. Klein

Download or read book Handbook of Survival Analysis written by John P. Klein and published by CRC Press. This book was released on 2016-04-19 with total page 635 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Survival Analysis presents modern techniques and research problems in lifetime data analysis. This area of statistics deals with time-to-event data that is complicated by censoring and the dynamic nature of events occurring in time. With chapters written by leading researchers in the field, the handbook focuses on advances in survival analysis techniques, covering classical and Bayesian approaches. It gives a complete overview of the current status of survival analysis and should inspire further research in the field. Accessible to a wide range of readers, the book provides: An introduction to various areas in survival analysis for graduate students and novices A reference to modern investigations into survival analysis for more established researchers A text or supplement for a second or advanced course in survival analysis A useful guide to statistical methods for analyzing survival data experiments for practicing statisticians

Statistical Issues in the Design and Analysis of Clinical Trials

Author : Yanning Liu
Publisher :
ISBN 13 : 9783659845543
Total Pages : 248 pages
Book Rating : 4.8/5 (455 download)

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Book Synopsis Statistical Issues in the Design and Analysis of Clinical Trials by : Yanning Liu

Download or read book Statistical Issues in the Design and Analysis of Clinical Trials written by Yanning Liu and published by . This book was released on 2017-01-11 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Analysing Survival Data from Clinical Trials and Observational Studies

Author : Ettore Marubini
Publisher : John Wiley & Sons
ISBN 13 : 9780470093412
Total Pages : 436 pages
Book Rating : 4.0/5 (934 download)

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Book Synopsis Analysing Survival Data from Clinical Trials and Observational Studies by : Ettore Marubini

Download or read book Analysing Survival Data from Clinical Trials and Observational Studies written by Ettore Marubini and published by John Wiley & Sons. This book was released on 2004-07-02 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to methods of survival analysis for medical researchers with limited statistical experience. Methods and techniques described range from descriptive and exploratory analysis to multivariate regression methods. Uses illustrative data from actual clinical trials and observational studies to describe methods of analysing and reporting results. Also reviews the features and performance of statistical software available for applying the methods of analysis discussed.

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.

Survival Analysis

Author : David G. Kleinbaum
Publisher : Springer Science & Business Media
ISBN 13 : 1475725558
Total Pages : 332 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Survival Analysis by : David G. Kleinbaum

Download or read book Survival Analysis written by David G. Kleinbaum and published by Springer Science & Business Media. This book was released on 2013-04-18 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: A straightforward and easy-to-follow introduction to the main concepts and techniques of the subject. It is based on numerous courses given by the author to students and researchers in the health sciences and is written with such readers in mind. A "user-friendly" layout includes numerous illustrations and exercises and the book is written in such a way so as to enable readers learn directly without the assistance of a classroom instructor. Throughout, there is an emphasis on presenting each new topic backed by real examples of a survival analysis investigation, followed up with thorough analyses of real data sets. Each chapter concludes with practice exercises to help readers reinforce their understanding of the concepts covered, before going on to a more comprehensive test. Answers to both are included. Readers will enjoy David Kleinbaums style of presentation, making this an excellent introduction for all those coming to the subject for the first time.

Bayesian Survival Analysis

Author : Joseph G. Ibrahim
Publisher : Springer Science & Business Media
ISBN 13 : 1475734476
Total Pages : 494 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Bayesian Survival Analysis by : Joseph G. Ibrahim

Download or read book Bayesian Survival Analysis written by Joseph G. Ibrahim and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Survival analysis arises in many fields of study including medicine, biology, engineering, public health, epidemiology, and economics. This book provides a comprehensive treatment of Bayesian survival analysis. It presents a balance between theory and applications, and for each class of models discussed, detailed examples and analyses from case studies are presented whenever possible. The applications are all from the health sciences, including cancer, AIDS, and the environment.

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

Survival Analysis with Interval-Censored Data

Author : Kris Bogaerts
Publisher : CRC Press
ISBN 13 : 1351643053
Total Pages : 644 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Survival Analysis with Interval-Censored Data by : Kris Bogaerts

Download or read book Survival Analysis with Interval-Censored Data written by Kris Bogaerts and published by CRC Press. This book was released on 2017-11-20 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: Survival Analysis with Interval-Censored Data: A Practical Approach with Examples in R, SAS, and BUGS provides the reader with a practical introduction into the analysis of interval-censored survival times. Although many theoretical developments have appeared in the last fifty years, interval censoring is often ignored in practice. Many are unaware of the impact of inappropriately dealing with interval censoring. In addition, the necessary software is at times difficult to trace. This book fills in the gap between theory and practice. Features: -Provides an overview of frequentist as well as Bayesian methods. -Include a focus on practical aspects and applications. -Extensively illustrates the methods with examples using R, SAS, and BUGS. Full programs are available on a supplementary website. The authors: Kris Bogaerts is project manager at I-BioStat, KU Leuven. He received his PhD in science (statistics) at KU Leuven on the analysis of interval-censored data. He has gained expertise in a great variety of statistical topics with a focus on the design and analysis of clinical trials. Arnošt Komárek is associate professor of statistics at Charles University, Prague. His subject area of expertise covers mainly survival analysis with the emphasis on interval-censored data and classification based on longitudinal data. He is past chair of the Statistical Modelling Society and editor of Statistical Modelling: An International Journal. Emmanuel Lesaffre is professor of biostatistics at I-BioStat, KU Leuven. His research interests include Bayesian methods, longitudinal data analysis, statistical modelling, analysis of dental data, interval-censored data, misclassification issues, and clinical trials. He is the founding chair of the Statistical Modelling Society, past-president of the International Society for Clinical Biostatistics, and fellow of ISI and ASA.