Handbook Of Adaptive Designs In Pharmaceutical And Clinical Development
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Author |
: Annpey Pong |
Publisher |
: CRC Press |
Total Pages |
: 475 |
Release |
: 2016-04-19 |
ISBN-10 |
: 9781439810170 |
ISBN-13 |
: 1439810176 |
Rating |
: 4/5 (70 Downloads) |
Synopsis Handbook of Adaptive Designs in Pharmaceutical and Clinical Development by : Annpey Pong
In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Total Pages |
: 368 |
Release |
: 2011-12-01 |
ISBN-10 |
: 9781439839881 |
ISBN-13 |
: 1439839883 |
Rating |
: 4/5 (81 Downloads) |
Synopsis Adaptive Design Methods in Clinical Trials by : Shein-Chung Chow
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed.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
Author |
: Scott M. Berry |
Publisher |
: CRC Press |
Total Pages |
: 316 |
Release |
: 2010-07-19 |
ISBN-10 |
: 9781439825518 |
ISBN-13 |
: 1439825513 |
Rating |
: 4/5 (18 Downloads) |
Synopsis Bayesian Adaptive Methods for Clinical Trials by : Scott M. Berry
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 Adapti
Author |
: Shayne Cox Gad |
Publisher |
: John Wiley & Sons |
Total Pages |
: 1247 |
Release |
: 2009-06-17 |
ISBN-10 |
: 9780470466353 |
ISBN-13 |
: 0470466359 |
Rating |
: 4/5 (53 Downloads) |
Synopsis Clinical Trials Handbook by : Shayne Cox Gad
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Author |
: Tom Brody |
Publisher |
: Academic Press |
Total Pages |
: 897 |
Release |
: 2016-02-19 |
ISBN-10 |
: 9780128042588 |
ISBN-13 |
: 0128042583 |
Rating |
: 4/5 (88 Downloads) |
Synopsis Clinical Trials by : Tom Brody
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author |
: John O'Quigley |
Publisher |
: CRC Press |
Total Pages |
: 306 |
Release |
: 2017-04-27 |
ISBN-10 |
: 9781498746113 |
ISBN-13 |
: 149874611X |
Rating |
: 4/5 (13 Downloads) |
Synopsis Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials by : John O'Quigley
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 |
: Shayne Cox Gad |
Publisher |
: Wiley |
Total Pages |
: 944 |
Release |
: 2009-06-17 |
ISBN-10 |
: 9780470466353 |
ISBN-13 |
: 0470466359 |
Rating |
: 4/5 (53 Downloads) |
Synopsis Clinical Trials Handbook by : Shayne Cox Gad
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Total Pages |
: 825 |
Release |
: 2017-08-15 |
ISBN-10 |
: 9781351727112 |
ISBN-13 |
: 1351727117 |
Rating |
: 4/5 (12 Downloads) |
Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow
Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.
Author |
: Menghis Bairu |
Publisher |
: Academic Press |
Total Pages |
: 428 |
Release |
: 2013-08-28 |
ISBN-10 |
: 9780124115309 |
ISBN-13 |
: 0124115306 |
Rating |
: 4/5 (09 Downloads) |
Synopsis Global Clinical Trials for Alzheimer's Disease by : Menghis Bairu
Global Clinical Trials for Alzheimer's Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer's disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer's disease. - Written by leading experts with hands-on experience in designing and running global Alzheimer's disease and other neurodegenerative diseases clinical trials - A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area - Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer's disease global clinical trials in emerging markets and developing countries
Author |
: Shein-Chung Chow |
Publisher |
: CRC Press |
Total Pages |
: 598 |
Release |
: 2016-04-19 |
ISBN-10 |
: 9781439849620 |
ISBN-13 |
: 1439849625 |
Rating |
: 4/5 (20 Downloads) |
Synopsis Controversial Statistical Issues in Clinical Trials by : Shein-Chung Chow
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials cov