Noninferiority Testing In Clinical Trials

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Noninferiority Testing In Clinical Trials

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Author : Tie-Hua Ng
language : en
Publisher: CRC Press
Release Date : 2014-12-01

Noninferiority Testing In Clinical Trials written by Tie-Hua Ng and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-01 with Mathematics categories.

Take Your NI Trial to the Next LevelReflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI test

Reinventing Regulation Of Drugs And Medical Devices

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Author : Bill Clinton
language : en
Publisher:
Release Date : 1995

Reinventing Regulation Of Drugs And Medical Devices written by Bill Clinton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Drugs categories.

Sample Sizes For Clinical Trials

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Author : Steven A. Julious
language : en
Publisher: CRC Press
Release Date : 2009-08-26

Sample Sizes For Clinical Trials written by Steven A. Julious and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-08-26 with Mathematics categories.

Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including su

Testing Statistical Hypotheses Of Equivalence And Noninferiority

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Author : Stefan Wellek
language : en
Publisher: CRC Press
Release Date : 2010-06-24

Testing Statistical Hypotheses Of Equivalence And Noninferiority written by Stefan Wellek and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-06-24 with Mathematics categories.

While continuing to focus on methods of testing for two-sided equivalence, Testing Statistical Hypotheses of Equivalence and Noninferiority, Second Edition gives much more attention to noninferiority testing. It covers a spectrum of equivalence testing problems of both types, ranging from a one-sample problem with normally distributed observations

Bayesian Adaptive Methods For Clinical Trials

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Author : Scott M. Berry
language : en
Publisher: CRC Press
Release Date : 2010-07-19

Bayesian Adaptive Methods For Clinical Trials written by Scott M. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-19 with Mathematics categories.

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 Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II–III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.

Practical Radiation Oncology

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Author : Supriya Mallick
language : en
Publisher: Springer Nature
Release Date : 2019-11-25

Practical Radiation Oncology written by Supriya Mallick and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-25 with Medical categories.

This book addresses the most relevant aspects of radiation oncology in terms of technical integrity, dose parameters, machine and software specifications, as well as regulatory requirements. Radiation oncology is a unique field that combines physics and biology. As a result, it has not only a clinical aspect, but also a physics aspect and biology aspect, all three of which are inter-related and critical to optimal radiation treatment planning. In addition, radiation oncology involves a host of machines/software. One needs to have a firm command of these machines and their specifications to deliver comprehensive treatment. However, this information is not readily available, which poses serious challenges for students learning the planning aspect of radiation therapy. In response, this book compiles these relevant aspects in a single source. Radiation oncology is a dynamic field, and is continuously evolving. However, tracking down the latest findings is both difficult and time-consuming. Consequently, the book also comprehensively covers the most important trials. Offering an essential ready reference work, it represents a value asset for all radiation oncology practitioners, trainees and students.

Guidelines For Treatment Of Drug Susceptible Tuberculosis And Patient Care

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Author : World Health Organization
language : en
Publisher:
Release Date : 2017-06

Guidelines For Treatment Of Drug Susceptible Tuberculosis And Patient Care written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06 with Medical categories.

The update of the Guidelines for Treatment of Drug-susceptible Tuberculosis and Patient Care is important in the context of the End TB Strategy, which recommends treatment and patient support for all people with TB. This update aims to use the best available evidence on the treatment of drug-susceptible TB and interventions to ensure adequate patient care and support in order to inform policy decisions made in these technical areas by national TB control program managers, national policy-makers, and medical practitioners in a variety of geographical, economic, and social settings. The objectives of these updated guidelines are to provide updated recommendations based on newly emerged evidence on the treatment of drug-susceptible TB and patient care as well as provide a summary of changes in the new guidelines with all the existing and valid WHO recommendations on the treatment of drug-susceptible TB and TB patient care. The key audience for these guidelines are policy-makers in ministries of health or managers of national TB programs who formulate country-specific TB treatment guidelines or who plan TB treatment programs. In addition, health professionals - including doctors, nurses, and educators working both in government services and nongovernmental organizations, such as technical agencies that are treating patients and organizing treatment services - will find these guidelines to be useful.

Design And Analysis Of Non Inferiority Trials

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Author : Mark D. Rothmann
language : en
Publisher: CRC Press
Release Date : 2011-07-12

Design And Analysis Of Non Inferiority Trials written by Mark D. Rothmann and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-12 with Mathematics categories.

The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority trial. Each chapter begins with a non-technical introduction, making the text easily understood by those without prior knowledge of this type of trial. Topics covered include: A variety of issues of non-inferiority trials, including multiple comparisons, missing data, analysis population, the use of safety margins, the internal consistency of non-inferiority inference, the use of surrogate endpoints, trial monitoring, and equivalence trials Specific issues and analysis methods when the data are binary, continuous, and time-to-event The history of non-inferiority trials and the design and conduct considerations for a non-inferiority trial The strength of evidence of an efficacy finding and how to evaluate the effect size of an active control therapy A comprehensive discussion on the purpose and issues involved with non-inferiority trials, Design and Analysis of Non-inferiority Trials will assist current and future scientists and statisticians on the optimal design of non-inferiority trials and in assessing the quality of non-inferiority comparisons done in practice.

Statistics In The Pharmaceutical Industry

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Author : C. Ralph Buncher
language : en
Publisher: CRC Press
Release Date : 2019-03-07

Statistics In The Pharmaceutical Industry written by C. Ralph Buncher and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-07 with Mathematics categories.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Multiple Testing Problems In Pharmaceutical Statistics

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Author : Alex Dmitrienko
language : en
Publisher: CRC Press
Release Date : 2009-12-08

Multiple Testing Problems In Pharmaceutical Statistics written by Alex Dmitrienko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-12-08 with Mathematics categories.

Useful Statistical Approaches for Addressing Multiplicity Issues Includes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings. The book begins with a broad introduction from a regulatory perspective to different types of multiplicity problems that commonly arise in confirmatory controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical methods for analyzing clinical dose response studies that compare several dose levels with a control as well as statistical methods for analyzing multiple endpoints in clinical trials. After covering gatekeeping procedures for testing hierarchically ordered hypotheses, the book discusses statistical approaches for the design and analysis of adaptive designs and related confirmatory hypothesis testing problems. The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur. This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications. It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice.