Statistical Methods For Survival Trial Design
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Statistical Methods For Survival Trial Design
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Author : Jianrong Wu
language : en
Publisher: CRC Press
Release Date : 2018-06-14
Statistical Methods For Survival Trial Design written by Jianrong Wu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-14 with Mathematics categories.
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
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Author : Jianrong Wu
language : en
Publisher: CRC Press
Release Date : 2018-06-14
Statistical Methods For Survival Trial Design written by Jianrong Wu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-14 with Mathematics categories.
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.
Sequential Experimentation In Clinical Trials
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Author : Jay Bartroff
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-12
Sequential Experimentation In Clinical Trials written by Jay Bartroff and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-12 with Medical categories.
Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.
Statistical Design Monitoring And Analysis Of Clinical Trials
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Author : Weichung Joe Shih
language : en
Publisher: CRC Press
Release Date : 2021-10-25
Statistical Design Monitoring And Analysis Of Clinical Trials written by Weichung Joe Shih and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-25 with Medical categories.
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.
Small Clinical Trials
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-02-01
Small Clinical Trials written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-02-01 with Medical categories.
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.
Bayesian Survival Analysis
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Author : Joseph G. Ibrahim
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-03-09
Bayesian Survival Analysis written by Joseph G. Ibrahim and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-09 with Medical categories.
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. Several topics are addressed, including parametric models, semiparametric models based on prior processes, proportional and non-proportional hazards models, frailty models, cure rate models, model selection and comparison, joint models for longitudinal and survival data, models with time varying covariates, missing covariate data, design and monitoring of clinical trials, accelerated failure time models, models for mulitivariate survival data, and special types of hierarchial survival models. Also various censoring schemes are examined including right and interval censored data. Several additional topics are discussed, including noninformative and informative prior specificiations, computing posterior qualities of interest, Bayesian hypothesis testing, variable selection, model selection with nonnested models, model checking techniques using Bayesian diagnostic methods, and Markov chain Monte Carlo (MCMC) algorithms for sampling from the posteiror and predictive distributions. The book 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 essentially from the health sciences, including cancer, AIDS, and the environment. The book is intended as a graduate textbook or a reference book for a one semester course at the advanced masters or Ph.D. level. This book would be most suitable for second or third year graduate students in statistics or biostatistics. It would also serve as a useful reference book for applied or theoretical researchers as well as practitioners.
Single Arm Phase Ii Survival Trial Design
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Author : Jianrong Wu
language : en
Publisher: CRC Press
Release Date : 2021-07-19
Single Arm Phase Ii Survival Trial Design written by Jianrong Wu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-07-19 with Mathematics categories.
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
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Author : Thomas D. Cook
language : en
Publisher: CRC Press
Release Date : 2007-11-19
Introduction To Statistical Methods For Clinical Trials written by Thomas D. Cook and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-19 with Mathematics categories.
This text provides a solid understanding of the various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. It covers basic experimental design, sample size, randomization procedures, interim and survival analyses, quality of life assessment, and longitudinal methods. The book describes all phases of a clinical trial and explores the advantages of and objections to the intent-to-treat principle as well as its implementation. With exercises at the end of most chapters, it also illustrates methods using examples with real data from a variety of disease areas, including heart and lung diseases, cancer, and AIDS.
Foundations Of Time Series Analysis And Prediction Theory
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Author : Mohsen Pourahmadi
language : en
Publisher: John Wiley & Sons
Release Date : 2001-06-01
Foundations Of Time Series Analysis And Prediction Theory written by Mohsen Pourahmadi and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-06-01 with Mathematics categories.
Foundations of time series for researchers and students This volume provides a mathematical foundation for time seriesanalysis and prediction theory using the idea of regression and thegeometry of Hilbert spaces. It presents an overview of the tools oftime series data analysis, a detailed structural analysis ofstationary processes through various reparameterizations employingtechniques from prediction theory, digital signal processing, andlinear algebra. The author emphasizes the foundation and structureof time series and backs up this coverage with theory andapplication. End-of-chapter exercises provide reinforcement for self-study andappendices covering multivariate distributions and Bayesianforecasting add useful reference material. Further coveragefeatures: * Similarities between time series analysis and longitudinal dataanalysis * Parsimonious modeling of covariance matrices through ARMA-likemodels * Fundamental roles of the Wold decomposition andorthogonalization * Applications in digital signal processing and Kalmanfiltering * Review of functional and harmonic analysis and predictiontheory Foundations of Time Series Analysis and Prediction Theory guidesreaders from the very applied principles of time series analysisthrough the most theoretical underpinnings of prediction theory. Itprovides a firm foundation for a widely applicable subject forstudents, researchers, and professionals in diverse scientificfields.
The Subjectivity Of Scientists And The Bayesian Approach
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Author : S. James Press
language : en
Publisher: John Wiley & Sons
Release Date : 2012-01-20
The Subjectivity Of Scientists And The Bayesian Approach written by S. James Press and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-20 with Mathematics categories.
Comparing and contrasting the reality of subjectivity in the workof history's great scientists and the modern Bayesian approach tostatistical analysis Scientists and researchers are taught to analyze their data from anobjective point of view, allowing the data to speak for themselvesrather than assigning them meaning based on expectations oropinions. But scientists have never behaved fully objectively.Throughout history, some of our greatest scientific minds haverelied on intuition, hunches, and personal beliefs to make sense ofempirical data-and these subjective influences have often aided inhumanity's greatest scientific achievements. The authors argue thatsubjectivity has not only played a significant role in theadvancement of science, but that science will advance more rapidlyif the modern methods of Bayesian statistical analysis replace someof the classical twentieth-century methods that have traditionallybeen taught. To accomplish this goal, the authors examine the lives and work ofhistory's great scientists and show that even the most successfulhave sometimes misrepresented findings or been influenced by theirown preconceived notions of religion, metaphysics, and the occult,or the personal beliefs of their mentors. Contrary to popularbelief, our greatest scientific thinkers approached their data witha combination of subjectivity and empiricism, and thus informallyachieved what is more formally accomplished by the modern Bayesianapproach to data analysis. Yet we are still taught that science is purely objective. Thisinnovative book dispels that myth using historical accounts andbiographical sketches of more than a dozen great scientists,including Aristotle, Galileo Galilei, Johannes Kepler, WilliamHarvey, Sir Isaac Newton, Antoine Levoisier, Alexander vonHumboldt, Michael Faraday, Charles Darwin, Louis Pasteur, GregorMendel, Sigmund Freud, Marie Curie, Robert Millikan, AlbertEinstein, Sir Cyril Burt, and Margaret Mead. Also included is adetailed treatment of the modern Bayesian approach to dataanalysis. Up-to-date references to the Bayesian theoretical andapplied literature, as well as reference lists of the primarysources of the principal works of all the scientists discussed,round out this comprehensive treatment of the subject. Readers will benefit from this cogent and enlightening view of thehistory of subjectivity in science and the authors' alternativevision of how the Bayesian approach should be used to further thecause of science and learning well into the twenty-first century.