Design And Analysis Of Non Inferiority Trials
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Design And Analysis Of Non Inferiority Trials
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Author : Mark D. Rothmann
language : en
Publisher: CRC Press
Release Date : 2016-04-19
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 2016-04-19 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 tr
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.
Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.
New Approaches To The Design And Analysis Of Non Inferiority Clinical Trials
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Author : Yulia Sidi
language : en
Publisher:
Release Date : 2020
New Approaches To The Design And Analysis Of Non Inferiority Clinical Trials written by Yulia Sidi and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with categories.
Clinical trials are an essential part of the drug development life cycle. There are different types of clinical trials, and in this dissertation, we focus on non-inferiority (NI) trials. In NI trials the goal is to show that the effectiveness of a new treatment is not considerably worse than of a standard one by an acceptable margin. Although, the new treatment could be slightly less efficacious, it can offer other benefits such as less severe adverse reactions. Several methodological challenges have been reported regarding the design, analysis and interpretation of NI trials. These include incomplete data analysis, specification of an acceptable margin, and overall benefit of the new non-inferior treatment. Therefore, the aim of this dissertation was to address each of these challenges and provide practical solutions for researchers involved with NI trials. First, we focus on incomplete data. Specifically, we evaluate how different statistical strategies perform under several NI scenarios and various types of missingness. We provide a set of recommendations for practitioners to use when confronted with incomplete data to avoid false non-inferiority conclusions. Second, while performing a thorough investigation of proper statistical strategies for incomplete data analysis, we discovered that combination rules of multiply imputed data when inference is done using a Newcombe's method did not exist. As a result, we developed these combination rules. Third, we proposed a new framework that allows for a transparent and objective justification of an acceptable margin. The framework is based on combining results of NI study and clinical experts survey data using multiple imputation (MI). Fourth, we developed a new approach for a comprehensive benefit-risk assessment of a non-inferior treatment. We focus on preference elicitation regarding benefits and risks from a small sample of NI trial participants, and use MI to restore preferences of all study participants. This dissertation provides an important contribution to the field of Statistics, and drug development. The novel methods and techniques outlined in this dissertation facilitate practitioners involved with NI trails to make more efficient and transparent evaluations of treatment effectiveness.
Small Clinical Trials
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-01-01
Small Clinical Trials written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-01-01 with Medical categories.
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
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
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
Sample Size Calculations In Clinical Research
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2017-08-15
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 2017-08-15 with Mathematics 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.
Textbook Of Clinical Trials In Oncology
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Author : Susan Halabi
language : en
Publisher: CRC Press
Release Date : 2019-04-24
Textbook Of Clinical Trials In Oncology written by Susan Halabi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-24 with Medical categories.
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others
Design And Analysis Of Quality Of Life Studies In Clinical Trials
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Author : Diane L. Fairclough
language : en
Publisher: CRC Press
Release Date : 2010-01-07
Design And Analysis Of Quality Of Life Studies In Clinical Trials written by Diane L. Fairclough and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-07 with Mathematics categories.
Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical meth