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Bayesian Adaptive Methods For Phase I Clinical Trials
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Book Synopsis Bayesian Adaptive Methods for Clinical Trials by : Scott M. Berry
Download or read book Bayesian Adaptive Methods for Clinical Trials written by Scott M. Berry and published by CRC Press. This book was released on 2010-07-19 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti
Book Synopsis Bayesian Adaptive Methods for Phase I Clinical Trials by : Ruitao Lin
Download or read book Bayesian Adaptive Methods for Phase I Clinical Trials written by Ruitao Lin and published by . This book was released on 2017-01-26 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Trial Design by : Guosheng Yin
Download or read book Clinical Trial Design written by Guosheng Yin and published by John Wiley & Sons. This book was released on 2013-06-07 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
Book Synopsis Bayesian Adaptive Methods to Incorporate Preclinical Data Into Phase I Clinical Trials by : Haiyan Zheng
Download or read book Bayesian Adaptive Methods to Incorporate Preclinical Data Into Phase I Clinical Trials written by Haiyan Zheng and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Bayesian Designs for Phase I-II Clinical Trials by : Ying Yuan
Download or read book Bayesian Designs for Phase I-II Clinical Trials written by Ying Yuan and published by CRC Press. This book was released on 2017-12-19 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.
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
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
Book Synopsis Modern Approaches to Clinical Trials Using SAS by : Sandeep Menon
Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.
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.
Book Synopsis Bayesian Adaptive Designs in Phase I/II Clinical Trials by : Wei Zhong
Download or read book Bayesian Adaptive Designs in Phase I/II Clinical Trials written by Wei Zhong and published by . This book was released on 2012 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods by : Sandeep Menon
Download or read book Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and 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, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. --
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Book Synopsis Bayesian Designs for Phase I-II Clinical Trials by : Ying Yuan
Download or read book Bayesian Designs for Phase I-II Clinical Trials written by Ying Yuan and published by CRC Press. This book was released on 2017-12-19 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.
Book Synopsis Bayesian Analysis with R for Drug Development by : Harry Yang
Download or read book Bayesian Analysis with R for Drug Development written by Harry Yang and published by CRC Press. This book was released on 2019-06-26 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.
Book Synopsis Bayesian Adaptive Dose-finding Clinical Trial Designs with Late-onset Outcomes by : Yifei Zhang
Download or read book Bayesian Adaptive Dose-finding Clinical Trial Designs with Late-onset Outcomes written by Yifei Zhang and published by . This book was released on 2021 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The late-onset outcome issue is common in early phase dose- nding clinical trials. This problem becomes more intractable in phase I/II clinical trials because both toxicity and e cacy responses are subject to the late-onset outcome issue. The existing methods applying for the phase I trials cannot be used directly for the phase I/II trial due to a lack of capability to model the joint toxicity{e cacy distribution. We propose a conditional weighted likelihood (CWL) method to circumvent this issue. The key idea of the CWL method is to decompose the joint probability into the product of marginal and conditional probabilities and then weight each probability based on each patient's actual follow-up time. We further extend the proposed method to handle more complex situations where the late-onset outcomes are competing risks or semicompeting risks outcomes. We treat the late-onset competing risks/semi-competing risks outcomes as missing data and develop a series of Bayesian data-augmentation methods to e ciently impute the missing data and draw the posterior samples of the parameters of interest. We also propose adaptive dose- nding algorithms to allocate patients and identify the optimal biological dose during the trial. Simulation studies show that the proposed methods yield desirable operating characteristics and outperform the existing methods.
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.
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.
