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Author : Wei Zhu
Publisher :
ISBN 13 :
Total Pages : 306 pages
Book Rating : 4.:/5 ( download)
Download or read book On the Optimal Designs of Multiple-objective Clinical Trials and Quantal Dose-response Experiments written by Wei Zhu and published by . This book was released on 1996 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : InYoung Baek
Publisher :
ISBN 13 :
Total Pages : 130 pages
Book Rating : 4.:/5 (717 download)
Download or read book Optimal Designs Accounting for Potential Missing Trials in Multiple-objective Dose Response Studies written by InYoung Baek and published by . This book was released on 2005 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Nancy Flournoy
Publisher : IMS
ISBN 13 : 9780940600461
Total Pages : 218 pages
Book Rating : 4.6/5 (4 download)
Download or read book New Developments and Applications in Experimental Design written by Nancy Flournoy and published by IMS. This book was released on 1998 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : John O'Quigley
Publisher : CRC Press
ISBN 13 : 149874611X
Total Pages : 306 pages
Book Rating : 4.4/5 (987 download)
Download or read book Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials written by John O'Quigley and published by CRC Press. This book was released on 2017-04-27 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.
Author : John O'Quigley
Publisher : CRC Press
ISBN 13 : 1351648020
Total Pages : 390 pages
Book Rating : 4.3/5 (516 download)
Download or read book Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials written by John O'Quigley and published by CRC Press. This book was released on 2017-04-27 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.
Author : Hui Kimko
Publisher : CRC Press
ISBN 13 : 0203910273
Total Pages : 424 pages
Book Rating : 4.2/5 (39 download)
Download or read book Simulation for Designing Clinical Trials written by Hui Kimko and published by CRC Press. This book was released on 2002-12-12 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Shein-Chung Chow
Publisher : John Wiley & Sons
ISBN 13 : 0471473294
Total Pages : 754 pages
Book Rating : 4.4/5 (714 download)
Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2008-12-04 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.
Author : Anthony C. Atkinson
Publisher : Springer Science & Business Media
ISBN 13 : 364258988X
Total Pages : 297 pages
Book Rating : 4.6/5 (425 download)
Download or read book MODA 5 - Advances in Model-Oriented Data Analysis and Experimental Design written by Anthony C. Atkinson and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume contains the majority of the papers presented at the 5th Inter national Workshop on Model-Oriented Data Analysis held in June 1998. This series started in March 1987 with a meeting on the Wartburg, Eisenach (Germany). The next three meetings were in 1990 (St Kyrik monastery, Bulgaria), 1992 (Petrodvorets, StPetersburg, Russia) and 1995 (Spetses, Greece). The main purpose of these workshops was to bring together lead ing scientists from 'Eastern' and 'Western' Europe for the exchange of ideas in theoretical and applied statistics, with special emphasis on experimen tal design. Now that the separation between East and West has become less rigid, this dialogue has, in principle, become much easier. However, providing opportunities for this dialogue is as vital as ever. MODA meetings are known for their friendly atmosphere, leading to fruitful discussions and collaboration, especially between young and senior scien tists. Indeed, many long term collaborations were initiated during these events. This intellectually stimulating atmosphere is achieved by limiting the number of participants to around eighty, by the choice of location so that participants can live as a community, and, of course, through the care ful selection of scientific direction made by the Programme Committee.
Author : Frank Miller
Publisher :
ISBN 13 :
Total Pages : 23 pages
Book Rating : 4.:/5 (254 download)
Download or read book Optimal Designs for Estimating the Interesting Part of a Dose-effect Curve written by Frank Miller and published by . This book was released on 2007 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Martijn P.F. Berger
Publisher : John Wiley & Sons
ISBN 13 : 9780470746929
Total Pages : 346 pages
Book Rating : 4.7/5 (469 download)
Download or read book An Introduction to Optimal Designs for Social and Biomedical Research written by Martijn P.F. Berger and published by John Wiley & Sons. This book was released on 2009-05-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: The increasing cost of research means that scientists are in more urgent need of optimal design theory to increase the efficiency of parameter estimators and the statistical power of their tests. The objectives of a good design are to provide interpretable and accurate inference at minimal costs. Optimal design theory can help to identify a design with maximum power and maximum information for a statistical model and, at the same time, enable researchers to check on the model assumptions. This Book: Introduces optimal experimental design in an accessible format. Provides guidelines for practitioners to increase the efficiency of their designs, and demonstrates how optimal designs can reduce a study’s costs. Discusses the merits of optimal designs and compares them with commonly used designs. Takes the reader from simple linear regression models to advanced designs for multiple linear regression and nonlinear models in a systematic manner. Illustrates design techniques with practical examples from social and biomedical research to enhance the reader’s understanding. Researchers and students studying social, behavioural and biomedical sciences will find this book useful for understanding design issues and in putting optimal design ideas to practice.
Author : David Harrington
Publisher : Springer Science & Business Media
ISBN 13 : 1461401402
Total Pages : 213 pages
Book Rating : 4.4/5 (614 download)
Download or read book Designs for Clinical Trials written by David Harrington and published by Springer Science & Business Media. This book was released on 2011-10-09 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Steven Piantadosi
Publisher : John Wiley & Sons
ISBN 13 : 1394195672
Total Pages : 789 pages
Book Rating : 4.3/5 (941 download)
Download or read book Clinical Trials written by Steven Piantadosi and published by John Wiley & Sons. This book was released on 2024-04-03 with total page 789 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials Comprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials The Fourth Edition of Clinical Trials builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results. Each chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge. Written by a highly qualified author with significant experience in the field, the Fourth Edition of Clinical Trials approaches the topic with: Problems that may arise during a trial, and accompanying common sense solutions Design alternatives for addressing many questions in therapeutic development Statistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and more Alternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care data Revamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures Standing out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, Clinical Trials is an essential learning aid on the subject for undergraduate and graduate clinical trials courses.
Author : Sarah R. Brown
Publisher : John Wiley & Sons
ISBN 13 : 1118763637
Total Pages : 260 pages
Book Rating : 4.1/5 (187 download)
Download or read book A Practical Guide to Designing Phase II Trials in Oncology written by Sarah R. Brown and published by John Wiley & Sons. This book was released on 2014-03-28 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: Offers a structured and practical approach to phase II trial design Considers trial design from both an academic and industry perspective Includes a structured library of available phase II trial designs Is relevant to both clinical and statistical researchers at all levels Includes real life examples of applying this approach For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.
Author : Mitchell Aaron Schepps
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (141 download)
Download or read book Designing Worldwide Clinical Trials with Multiple Objectives Using Nature-Inspired Metaheuristic Algorithms written by Mitchell Aaron Schepps and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Problems in healthcare and medicine are worldwide and multifaceted. This dissertation explores optimal and efficient designs in global and other important clinical trials with nature-inspired metaheuristic algorithms. The primary objective of this research is to showcase novel uses of metaheuristics in two real world applications: first, we collaborate with physicians and help patients with bipolar disorder by designing optimal sampling times for sustained-release lithium, a vital medication using pharmacokinetics/pharmacodynamics nonlinear mixed effects models and second, to optimize worldwide clinical trial patient recruitment plans within tight, real world complex regulatory and budgetary constraints. We determine interesting optimal designs using metaheuristics in both single and multiple objective situations with complex constraints. We show systematic analyses which can be used to solve and enhance the implementation and interpretability of the discussed real life clinical trial designs. The results from this dissertation are implemented in current software and offer novel insights into the design of experiments and patient recruitment strategies, contributing to the advancement of medical treatments and healthcare practices.
Author :
Publisher :
ISBN 13 :
Total Pages : 876 pages
Book Rating : 4.3/5 (91 download)
Download or read book Journal of the American Statistical Association written by and published by . This book was released on 2008 with total page 876 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Yevgen Ryeznik
Publisher :
ISBN 13 : 9789150627480
Total Pages : pages
Book Rating : 4.6/5 (274 download)
Download or read book Optimal Adaptive Designs and Adaptive Randomization Techniques for Clinical Trials written by Yevgen Ryeznik and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ping Yao (Ph. D.)
Publisher :
ISBN 13 :
Total Pages : 60 pages
Book Rating : 4.:/5 (697 download)
Download or read book Adaptive Optimal Design with Application to a Two Drug Combination Trial Based on Efficiency-toxicity Response written by Ping Yao (Ph. D.) and published by . This book was released on 2009 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first part of this dissertation develops an adaptive optimal design for dose-finding with combination therapies that accounts for both efficacy and toxicity. The bivariate probit model is used as a working model for the dose-response relationship. A desirable therapy is defined to be the dose combination that achieves a preset probability of efficacy and toxicity. The goal is to estimate the dose that exists closest to the desirable therapy, but within the therapeutic range. A-optimal designs that minimizes the variance of the estimate of this dose and D-optimal designs that minimize the (approximate) confidence ellipsoid for all model parameters are obtained. The next part addresses important outstanding questions concerning the information measure used in implementing adaptive optimal designs. Four measures of information are important in the literature on inference for stochastic processes. The measure used in adaptive optimal designs to construct treatment allocation procedures is none of these. I explore these information measures in the context of adaptive optimal designs.
