Clinical Trial Simulations Using R
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Clinical Trial Simulations Using R
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Author : Seth Berry
language : en
Publisher:
Release Date : 2017
Clinical Trial Simulations Using R written by Seth Berry and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with MEDICAL categories.
Clinical Trial Data Analysis Using R
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Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2010-12-14
Clinical Trial Data Analysis Using R 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.
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials
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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2019-03-20
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials written by Mark Chang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-20 with Mathematics categories.
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Clinical Trial Data Analysis Using R And Sas
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Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2017-06-01
Clinical Trial Data Analysis Using R And Sas 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 2017-06-01 with Mathematics categories.
Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.
Principles And Practice Of Clinical Trials
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Author : Steven Piantadosi
language : en
Publisher: Springer Nature
Release Date : 2022-07-19
Principles And Practice Of Clinical Trials written by Steven Piantadosi and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-07-19 with Medical categories.
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.
Monte Carlo Simulation For The Pharmaceutical Industry
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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2010-09-29
Monte Carlo Simulation For The Pharmaceutical Industry written by Mark Chang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-29 with Mathematics categories.
Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and metho
Clinical Trial Optimization Using R
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Author : Alex Dmitrienko
language : en
Publisher: CRC Press
Release Date : 2019-03-22
Clinical Trial Optimization Using R written by Alex Dmitrienko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-22 with categories.
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
Clinical Trial Optimization Using R
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Author : Alex Dmitrienko
language : en
Publisher: CRC Press
Release Date : 2017-08-10
Clinical Trial Optimization Using R written by Alex Dmitrienko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-10 with Mathematics categories.
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
Clinical Trial Simulations
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Author : Holly H. C. Kimko
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-12-09
Clinical Trial Simulations written by Holly H. C. Kimko 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 2010-12-09 with Medical categories.
This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
Simulation For Designing Clinical Trials
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Author : Hui Kimko
language : en
Publisher: CRC Press
Release Date : 2002-12-12
Simulation For Designing Clinical Trials written by Hui Kimko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-12-12 with Medical categories.
Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation p