Testing Statistical Hypotheses Of Equivalence And Noninferiority

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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

Testing Statistical Hypotheses Of Equivalence

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Author : Stefan Wellek
language : en
Publisher: CRC Press
Release Date : 2002-11-12

Testing Statistical Hypotheses Of Equivalence 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 2002-11-12 with Mathematics categories.

Equivalence testing has grown significantly in importance over the last two decades, especially as its relevance to a variety of applications has become understood. Yet published work on the general methodology remains scattered in specialists' journals, and for the most part, it focuses on the relatively narrow topic of bioequivalence assessment.

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 Level Reflecting 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 testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.

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

Handbook Of Statistical Methods For Randomized Controlled Trials

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Author : KyungMann Kim
language : en
Publisher: CRC Press
Release Date : 2021-08-23

Handbook Of Statistical Methods For Randomized Controlled Trials written by KyungMann Kim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-23 with Mathematics categories.

Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.

Innovative Statistics In Regulatory Science

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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2019-11-14

Innovative Statistics In Regulatory Science 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 2019-11-14 with Mathematics categories.

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Clinical Trials In Neurology

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Author : Bernard Ravina
language : en
Publisher: Cambridge University Press
Release Date : 2012-04-12

Clinical Trials In Neurology written by Bernard Ravina and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-12 with Medical categories.

Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.

Automotive Ergonomics

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Author : Heiner Bubb
language : en
Publisher: Springer Nature
Release Date : 2021-10-19

Automotive Ergonomics written by Heiner Bubb and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-19 with Technology & Engineering categories.

Ergonomics teaches how to design technology in such a way that it is optimally adapted to the needs, wishes and characteristics of the user. In this context, the concept of the human-machine system has become established. In a systematic way and with a detailed view of the complicated technical and perceptual psychological and methodological connections, this book explains the basics of automotive ergonomics with numerous examples. The application is shown in examples such as package, design of displays and control elements, of environmental ergonomics such as lighting, sound, vibrations, climate and smell. The design of driver assistance systems from an ergonomic perspective is also a central topic. The book is rounded off by methods of ergonomic vehicle development, the use of mock-ups, driving simulators and tests in real vehicles and prototypes. For the first time, those responsible in the automotive industry and in the field of relevant research are provided with a specialized systematic work that provides the ergonomic findings in the design of today's automobiles. This provides planners and designers of today's automobiles with concrete information for ergonomic product development, enabling them to keep an eye on decisive requirements and subsequent customer acceptance. This book is a translation of the original German 1st edition Automobilergonomie by Heiner Bubb, Klaus Bengler, Rainer E. Grünen & Mark Vollrath, published by Springer Fachmedien Wiesbaden GmbH, part of Springer Nature in 2015. The translation was done with the help of artificial intelligence (machine translation by the service DeepL.com). A subsequent human revision was done primarily in terms of content, so that the book will read stylistically differently from a conventional translation. Springer Nature works continuously to further the development of tools for the production of books and on the related technologies to support the authors.

Sample Size Calculations In Clinical Research

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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2020-09-30

Sample Size Calculations In Clinical Research 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 2020-09-30 with categories.

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.

Modern Issues And Methods In Biostatistics

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Author : Mark Chang
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-07-15

Modern Issues And Methods In Biostatistics written by Mark Chang and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-15 with Medical categories.

Classic biostatistics, a branch of statistical science, has as its main focus the applications of statistics in public health, the life sciences, and the pharmaceutical industry. Modern biostatistics, beyond just a simple application of statistics, is a confluence of statistics and knowledge of multiple intertwined fields. The application demands, the advancements in computer technology, and the rapid growth of life science data (e.g., genomics data) have promoted the formation of modern biostatistics. There are at least three characteristics of modern biostatistics: (1) in-depth engagement in the application fields that require penetration of knowledge across several fields, (2) high-level complexity of data because they are longitudinal, incomplete, or latent because they are heterogeneous due to a mixture of data or experiment types, because of high-dimensionality, which may make meaningful reduction impossible, or because of extremely small or large size; and (3) dynamics, the speed of development in methodology and analyses, has to match the fast growth of data with a constantly changing face. This book is written for researchers, biostatisticians/statisticians, and scientists who are interested in quantitative analyses. The goal is to introduce modern methods in biostatistics and help researchers and students quickly grasp key concepts and methods. Many methods can solve the same problem and many problems can be solved by the same method, which becomes apparent when those topics are discussed in this single volume.