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Author: Guosheng Yin
Publisher: John Wiley & Sons
ISBN: 0470581719
Category : Medical
Languages : en
Pages : 368
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Book Description
A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
Author: Guosheng Yin
Publisher: John Wiley & Sons
ISBN: 0470581719
Category : Medical
Languages : en
Pages : 368
Get Book Here
Book Description
A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
Author: Karl E. Peace
Publisher: CRC Press
ISBN: 1584889187
Category : Mathematics
Languages : en
Pages : 422
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Book Description
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors' courses on the subject as well as the first author's more than 30 years wor
Author: Francis Hargrave
Publisher:
ISBN:
Category :
Languages : en
Pages : 1156
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Book Description
Author: Thomas Bayly Howell
Publisher:
ISBN:
Category : Trials
Languages : en
Pages : 784
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Book Description
Author: Thomas A. Mauet
Publisher: Wolters Kluwer
ISBN: 156706941X
Category : Law
Languages : en
Pages : 194
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Book Description
When you go to trial, an efficient system of organizational management is crucial. Mauet's system is widely relied upon as the one that provides everything you need to prepare logically and efficiently for any kind of case. In the first trial notebook system to include computerized document forms, Mauet makes it easy to: Organize your testimony, exhibits, research -- everything you need to try your case -- Choose your own categories to assemble all necessary information -- Summarize the motions and filings you must make -- and when to make them -- Develop a trial strategy. You'll have proven, easy-to-use forms (both paper and electronic) for: Reviewing legal elements of claims and defenses -- Jury selection -- Exhibits -- Examination of witnesses -- Closing argument and opening statement. You'll also get the Federal Rules of Evidence, Civil Procedure, and Criminal Procedure -- plus Mauet's incomparable strategic advice.
Author: Olivia Smith
Publisher: Springer
ISBN: 3319756745
Category : Social Science
Languages : en
Pages : 292
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Book Description
In light of ongoing concerns about the treatment of survivors, Rape Trials in England and Wales critically examines court responses to rape and sexual assault. Using new data from an in-depth observational study of rape trials, this book asks why attempts to improve survivor experiences at court have not been fully effective. In doing so, Smith identifies deep-rooted barriers to survivor justice and, crucially, introduces potential avenues for more effective reform. This book provides a comprehensive examination of the practicalities of court, use of rape myths and sexual history evidence, underlying principles of adversarial justice and the impact of inequalities embedded within English and Welsh legal culture. This engaging and highly significant study is essential reading for anyone seeking to understand the criminal courts and their responses to rape, including practitioners and students of criminology, sociology, and law.
Author: Henry A. Glick
Publisher: Handbooks in Health Economic E
ISBN: 0199685029
Category : Business & Economics
Languages : en
Pages : 265
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Book Description
It is increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. This book provides a practical guide to the techniques and issues involved in conducting economic evaluation in ongoing clinical trials, supported with examples.
Author: Ying Yuan
Publisher: CRC Press
ISBN: 1315354225
Category : Mathematics
Languages : en
Pages : 233
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Book Description
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: Malte Renz
Publisher: CRC Press
ISBN: 1000783642
Category : Medical
Languages : en
Pages : 222
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Book Description
This revised and updated new edition of a best-selling text remains a fast and convenient overview of the clinical trials in gynecologic cancer treatment, outlining the evidence base of treatment decisions in uterine, ovarian, cervical, and vulvar cancers, and gestational trophoblastic neoplasia. Residents and fellows will find this book an indispensable reference, while practitioners will welcome it as a clarification of the evidence base for treatment options. *Gives a convenient summary of trials in gynecologic oncology *Supplies an invaluable revision primer for those undertaking certification *Provides a uniquely up-to-date resource
Author: Ronald K. L. Collins
Publisher: Top Five Books LLC
ISBN: 1938938011
Category :
Languages : en
Pages : 712
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Book Description
“The book is indispensable.” —Booklist “Detailed, objective, and valuable.” —Kirkus Reviews “Generating a gamut of emotions, the entire package is an important documentation of a revolution in American culture.” —Publishers Weekly 10th Anniversary Edition—Includes a New Preface by the Authors When it first came out in 2002, The Trials of Lenny Bruce quickly established itself as the definitive work on Lenny Bruce’s free speech battles over his provocative comedy. Originally packaged with an audio CD, this 10th Anniversary Enhanced eBook edition includes audio from Lenny Bruce’s most controversial performances, as well as exclusive author interviews with George Carlin, Hugh Hefner, Paul Krassner, Margaret Cho, and the lawyers who defended and prosecuted him. Also included are archival audio clips secretly recorded during Lenny’s New York obscenity trial. The Trials of Lenny Bruce is an important document of the free speech struggles of an icon of American comedy who, by speaking his mind and fighting the good fight, paved the way for every standup comedian, satirist, and social critic who followed him. Not only did The Trials of Lenny Bruce set the record straight on Lenny, being named one of the best books of the year by the L.A. Times, the authors led the successful push for the late comedian’s posthumous pardon in 2003 for his 1964 conviction on obscenity charges in New York.