Bayesian Methods For Measures Of Agreement
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Bayesian Methods For Measures Of Agreement
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Author : Lyle D. Broemeling
language : en
Publisher: CRC Press
Release Date : 2009-01-12
Bayesian Methods For Measures Of Agreement written by Lyle D. Broemeling and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-01-12 with Mathematics categories.
Using WinBUGS to implement Bayesian inferences of estimation and testing hypotheses, Bayesian Methods for Measures of Agreement presents useful methods for the design and analysis of agreement studies. It focuses on agreement among the various players in the diagnostic process.The author employs a Bayesian approach to provide statistical inferences
Randomization Masking And Allocation Concealment
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Author : Vance Berger
language : en
Publisher: CRC Press
Release Date : 2017-10-30
Randomization Masking And Allocation Concealment written by Vance Berger and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-10-30 with Mathematics categories.
Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these methods correctly. Far too often the subtle nuances that distinguish proper randomization from flawed randomization are completely ignored in trial reports that state only that randomization was used, with no additional information. Experience has shown that in many cases, the type of randomization that was used was flawed. It is only a matter of time before medical journals and regulatory agencies come to realize that we can no longer rely on (or publish) flawed trials, and that flawed randomization in and of itself disqualifies a trial from being robust or high quality, even if that trial is of high quality otherwise. This book will help to clarify the role randomization plays in ensuring internal validity, and in drawing valid inferences from the data. The various chapters cover a variety of randomization methods, and are not limited to the most common (and most flawed) ones. Readers will come away with a profound understanding of what constitutes a valid randomization procedure, so that they can distinguish the valid from the flawed among not only existing methods but also methods yet to be developed.
Optimal Design For Nonlinear Response Models
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Author : Valerii V. Fedorov
language : en
Publisher: CRC Press
Release Date : 2013-07-15
Optimal Design For Nonlinear Response Models written by Valerii V. Fedorov and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-15 with Mathematics categories.
Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors’ many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of the key ideas, using linear models as examples. Applying the linearization in the parameter space, it then covers nonlinear models and locally optimal designs as well as minimax, optimal on average, and Bayesian designs. The authors also discuss adaptive designs, focusing on procedures with non-informative stopping. The common goals of experimental design—such as reducing costs, supporting efficient decision making, and gaining maximum information under various constraints—are often the same across diverse applied areas. Ethical and regulatory aspects play a much more prominent role in biological, medical, and pharmaceutical research. The authors address all of these issues through many examples in the book.
Biosimilars
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2013-07-29
Biosimilars 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 2013-07-29 with Mathematics categories.
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf
Randomized Phase Ii Cancer Clinical Trials
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Author : Sin-Ho Jung
language : en
Publisher: CRC Press
Release Date : 2013-05-02
Randomized Phase Ii Cancer Clinical Trials written by Sin-Ho Jung and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-02 with Mathematics categories.
In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biosta
Design And Analysis Of Clinical Trials For Predictive Medicine
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Author : Shigeyuki Matsui
language : en
Publisher: CRC Press
Release Date : 2015-03-19
Design And Analysis Of Clinical Trials For Predictive Medicine written by Shigeyuki Matsui and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-19 with Mathematics categories.
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming
Data Analysis With Competing Risks And Intermediate States
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Author : Ronald B. Geskus
language : en
Publisher: CRC Press
Release Date : 2015-07-14
Data Analysis With Competing Risks And Intermediate States written by Ronald B. Geskus and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-14 with Mathematics categories.
This practical and thorough book explains when and how to use models and techniques for the analysis of competing risks and intermediate states. It covers the most recent insights on estimation techniques and discusses in detail how to interpret the obtained results. Each chapter includes standard exercises; a software section on SAS, Stata, and R; and computer practicals that allow readers to practice with the techniques. The book's website provides the R code for the computer practicals along with other material.
Statistical Topics In Health Economics And Outcomes Research
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Author : Demissie Alemayehu, PhD
language : en
Publisher: CRC Press
Release Date : 2017-11-22
Statistical Topics In Health Economics And Outcomes Research written by Demissie Alemayehu, PhD and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Mathematics categories.
With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.
Data And Safety Monitoring Committees In Clinical Trials Second Edition
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Author : Jay Herson
language : en
Publisher: CRC Press
Release Date : 2016-12-19
Data And Safety Monitoring Committees In Clinical Trials Second Edition written by Jay Herson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-19 with Mathematics categories.
Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician ? In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. ? New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members ? Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry. ? ? ? ? ? ? ? ? ? ? ? ? ?
Cancer Clinical Trials
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Author : Stephen L. George
language : en
Publisher: CRC Press
Release Date : 2016-08-19
Cancer Clinical Trials written by Stephen L. George and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-19 with Mathematics categories.
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.