Simulation For Designing Clinical Trials PDF Download
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Author | : Hui Kimko |
Publisher | : CRC Press |
Total Pages | : 424 |
Release | : 2002-12-12 |
Genre | : Medical |
ISBN | : 0203910273 |
Download Simulation for Designing Clinical Trials Book in PDF, ePub and Kindle
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
Author | : Holly H. C. Kimko |
Publisher | : Springer Science & Business Media |
Total Pages | : 540 |
Release | : 2010-12-09 |
Genre | : Medical |
ISBN | : 1441974156 |
Download Clinical Trial Simulations Book in PDF, ePub and Kindle
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.
Author | : Holly H. C. Kimko |
Publisher | : Springer |
Total Pages | : 540 |
Release | : 2010-12-10 |
Genre | : Medical |
ISBN | : 9781441974143 |
Download Clinical Trial Simulations Book in PDF, ePub and Kindle
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.
Author | : Mark Chang |
Publisher | : CRC Press |
Total Pages | : 218 |
Release | : 2019-03-20 |
Genre | : Mathematics |
ISBN | : 1351214527 |
Download Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials Book in PDF, ePub and Kindle
"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.
Author | : Lin Xie |
Publisher | : |
Total Pages | : 206 |
Release | : 1999 |
Genre | : |
ISBN | : |
Download Simulation Aided Clinical Trials Design Book in PDF, ePub and Kindle
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 221 |
Release | : 2001-01-01 |
Genre | : Medical |
ISBN | : 0309171148 |
Download Small Clinical Trials Book in PDF, ePub and Kindle
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.
Author | : Shein-Chung Chow |
Publisher | : CRC Press |
Total Pages | : 296 |
Release | : 2006-11-16 |
Genre | : Mathematics |
ISBN | : 158488777X |
Download Adaptive Design Methods in Clinical Trials Book in PDF, ePub and Kindle
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
Author | : Ying Yuan |
Publisher | : CRC Press |
Total Pages | : 238 |
Release | : 2017-12-19 |
Genre | : Mathematics |
ISBN | : 1315354225 |
Download Bayesian Designs for Phase I-II Clinical Trials Book in PDF, ePub and Kindle
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.
Author | : David Harrington |
Publisher | : Springer Science & Business Media |
Total Pages | : 213 |
Release | : 2011-10-09 |
Genre | : Medical |
ISBN | : 1461401402 |
Download Designs for Clinical Trials Book in PDF, ePub and Kindle
This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.
Author | : Shein-Chung Chow |
Publisher | : CRC Press |
Total Pages | : 368 |
Release | : 2011-12-01 |
Genre | : Mathematics |
ISBN | : 1439839883 |
Download Adaptive Design Methods in Clinical Trials Book in PDF, ePub and Kindle
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