free web tracker

Adaptive Design Methods In Clinical Trials


Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2006-11-16


PDF Download Adaptive Design Methods In Clinical Trials Books For free written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-11-16 with Mathematics categories.


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 that are based on accrued data of ongoing clinical trials. The book also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. After an introduction to basic concepts and statistical considerations of adaptive design methods, the book questions the impact on target patient populations as the result of protocol amendments and discusses the generalization of statistical inference. The authors also present various adaptive design methods, including where hypotheses are modified during the conduct of clinical trials, for dose selection, and commonly used adaptive group sequential design methods in clinical trials. Following a discussion of blind procedures for sample size re-estimation, the book describes statistical tests for seamless phase II/III adaptive designs and statistical inference for switching adaptively from one treatment to another. The book concludes with computer simulations and various case studies of clinical trials. By providing theoretical and computer simulation results, method comparisons, and practical guidelines for choosing an optimal design, Adaptive Design Methods in Clinical Trials fills the need for a unified, comprehensive, and updated resource in the clinical research and development of adaptive design and analysis.

Bayesian Adaptive Methods For Clinical Trials


Author : Scott M. Berry
language : en
Publisher: CRC Press
Release Date : 2010-07-19


PDF Download Bayesian Adaptive Methods For Clinical Trials Books For free written by Scott M. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-19 with Mathematics categories.


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 Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II–III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.

Oncology Clinical Trials


Author : William Kevin Kelly, DO
language : en
Publisher: Springer Publishing Company
Release Date : 2018-03-28


PDF Download Oncology Clinical Trials Books For free written by William Kevin Kelly, DO and has been published by Springer Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.


The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Advances In Clinical Trial Biostatistics


Author : Nancy L. Geller
language : en
Publisher: CRC Press
Release Date : 2003-10-21


PDF Download Advances In Clinical Trial Biostatistics Books For free written by Nancy L. Geller and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-10-21 with Mathematics categories.


From aspects of early trials to complex modeling problems, Advances in Clinical Trial Biostatistics summarizes current methodologies used in the design and analysis of clinical trials. Its chapters, contributed by internationally renowned methodologists experienced in clinical trials, address topics that include Bayesian methods for phase I clinical trials, adaptive two-stage clinical trials, and the design and analysis of cluster randomization trials, trials with multiple endpoints, and therapeutic equivalence trials. Other discussions explore Bayesian reporting, methods incorporating compliance in treatment evaluation, and statistical issues emerging from clinical trials in HIV infection.

Clinical Trial Methodology


Author : Karl E. Peace
language : en
Publisher: CRC Press
Release Date : 2010-07-20


PDF Download Clinical Trial Methodology Books For free written by Karl E. Peace and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-20 with Mathematics categories.


Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors’ courses on the subject as well as the first author’s more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors’ own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer’s disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence.

Clinical Trial Data Analysis Using R


Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2010-12-14


PDF Download Clinical Trial Data Analysis Using R Books For free written by Ding-Geng (Din) Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-14 with Mathematics categories.


Too often in biostatistical research and clinical trials, a knowledge gap exists between developed statistical methods and the applications of these methods. Filling this gap, Clinical Trial Data Analysis Using R provides a thorough presentation of biostatistical analyses of clinical trial data and shows step by step how to implement the statistical methods using R. The book’s practical, detailed approach draws on the authors’ 30 years of real-world experience in biostatistical research and clinical development. Each chapter presents examples of clinical trials based on the authors’ actual experiences in clinical drug development. Various biostatistical methods for analyzing the data are then identified. The authors develop analysis code step by step using appropriate R packages and functions. This approach enables readers to gain an understanding of the analysis methods and R implementation so that they can use R to analyze their own clinical trial data. With step-by-step illustrations of R implementations, this book shows how to easily use R to simulate and analyze data from a clinical trial. It describes numerous up-to-date statistical methods and offers sound guidance on the processes involved in clinical trials.

Statistical Methods For Survival Trial Design


Author : Jianrong Wu
language : en
Publisher: CRC Press
Release Date : 2018-06-14


PDF Download Statistical Methods For Survival Trial Design Books For free 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.