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Testing Statistical Hypotheses Of Equivalence And Noninferiority Second Edition

Author: Stefan Wellek
Publisher: CRC Press
ISBN: 9781439808191
Size: 11.15 MB
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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 of fixed known variance to problems involving several dependent or independent samples and multivariate data. Along with expanding the material on noninferiority problems, this edition includes new chapters on equivalence tests for multivariate data and tests for relevant differences between treatments. A majority of the computer programs offered online are now available not only in SAS or Fortran but also as R scripts or as shared objects that can be called within the R system. This book provides readers with a rich repertoire of efficient solutions to specific equivalence and noninferiority testing problems frequently encountered in the analysis of real data sets. It first presents general approaches to problems of testing for noninferiority and two-sided equivalence. Each subsequent chapter then focuses on a specific procedure and its practical implementation. The last chapter describes basic theoretical results about tests for relevant differences as well as solutions for some specific settings often arising in practice. Drawing from real-life medical research, the author uses numerous examples throughout to illustrate the methods.

Biostatistics For Medical And Biomedical Practitioners

Author: Julien I. E. Hoffman
Publisher: Academic Press
ISBN: 0128026073
Size: 33.49 MB
Format: PDF, Kindle
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Biostatistics for Practitioners: An Interpretative Guide for Medicine and Biology deals with several aspects of statistics that are indispensable for researchers and students across the biomedical sciences. The book features a step-by-step approach, focusing on standard statistical tests, as well as discussions of the most common errors. The book is based on the author’s 40+ years of teaching statistics to medical fellows and biomedical researchers across a wide range of fields. Discusses how to use the standard statistical tests in the biomedical field, as well as how to make statistical inferences (t test, ANOVA, regression etc.) Includes non-standards tests, including equivalence or non-inferiority testing, extreme value statistics, cross-over tests, and simple time series procedures such as the runs test and Cusums Introduces procedures such as multiple regression, Poisson regression, meta-analysis and resampling statistics, and provides references for further studies

Statistical Hypothesis Testing

Author: Ning-Zhong Shi
Publisher: World Scientific Publishing Company
ISBN: 9813107219
Size: 69.55 MB
Format: PDF, Kindle
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This book presents up-to-date theory and methods of statistical hypothesis testing based on measure theory. The so-called statistical space is a measurable space adding a family of probability measures. Most topics in the book will be developed based on this term. The book includes some typical data sets, such as the relation between race and the death penalty verdict, the behavior of food intake of two kinds of Zucker rats, and the per capita income and expenditure in China during the 1978–2002 period. Emphasis is given to the process of finding appropriate statistical techniques and methods of evaluating these techniques.

Noninferiority Testing In Clinical Trials

Author: Tie-Hua Ng
Publisher: CRC Press
ISBN: 1466561491
Size: 21.64 MB
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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 Size Calculations In Clinical Research Third Edition

Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1351727117
Size: 32.84 MB
Format: PDF
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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. ?

Statistics Applied To Clinical Trials

Author: Ton J. Cleophas
Publisher: Springer Science & Business Media
ISBN: 9401002851
Size: 36.18 MB
Format: PDF, ePub
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The authors have taught statistics and given statistics workshops in France and the Netherlands for almost 4 years by now. Their material, mainly on power point, consists of 12 lectures that have been continuously changed and improved by interaction with various audiences. For the purpose of the current book simple English text has been added to the formulas and figures, and the power points sheets have been rewritten in the format given by Kluwer Academic Publishers. Cartoons have been removed, since this is not so relevant for the transmission of thought through a written text, and at the end of each lecture (chapter) a representative number of questions and exercises for self-assessment have been added. At the end of the book detailed answers to the questions and exercises per lecture are given. The book has been produced with the same size and frontpage as the textbook "Statistics Applied To Clinical Trials" by the same authors and edited by same publishers ( 2nd Edition, DordrechtiBostonlLondon, 2002), and can be applied together with the current self-assessment book or separately. The current self-assessment book is different from the texbook, because it focuses on the most important aspects rather than trying to be complete. So, it does not deal with all of the subjects assessed in the texbook. Instead, it repeats on and on the principle things that are needed for every analysis, and it gives many examples that are further explained by arrows in the figures.

Multiple Comparisons

Author: Jason Hsu
Publisher: CRC Press
ISBN: 9780412982811
Size: 17.95 MB
Format: PDF, ePub, Docs
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Multiple Comparisons introduces simultaneous statistical inference and covers the theory and techniques for all-pairwise comparisons, multiple comparisons with the best, and multiple comparisons with a control. The author describes confidence intervals methods and stepwise exposes abuses and misconceptions, and guides readers to the correct method for each problem. Discussions also include the connections with bioequivalence, drug stability, and toxicity studies Real data sets analyzed by computer software packages illustrate the applications presented.

Clinical Data Analysis On A Pocket Calculator

Author: Ton J. Cleophas
Publisher: Springer
ISBN: 3319271040
Size: 11.68 MB
Format: PDF
View: 232
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In medical and health care the scientific method is little used, and statistical software programs are experienced as black box programs producing lots of p-values, but little answers to scientific questions. The pocket calculator analyses appears to be, particularly, appreciated, because they enable medical and health professionals and students for the first time to understand the scientific methods of statistical reasoning and hypothesis testing. So much so, that it can start something like a new dimension in their professional world. In addition, a number of statistical methods like power calculations and required sample size calculations can be performed more easily on a pocket calculator, than using a software program. Also, there are some specific advantages of the pocket calculator method. You better understand what you are doing. The pocket calculator works faster, because far less steps have to be taken, averages can be used. The current nonmathematical book is complementary to the nonmathematical "SPSS for Starters and 2nd Levelers" (Springer Heidelberg Germany 2015, from the same authors), and can very well be used as its daily companion.

Bioequivalence And Statistics In Clinical Pharmacology Second Edition

Author: Scott D. Patterson
Publisher: CRC Press
ISBN: 1466585218
Size: 11.44 MB
Format: PDF, ePub, Mobi
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Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established,?including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials.? This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Statistics In Medicine

Author: Robert H. Riffenburgh
Publisher: Academic Press
ISBN: 0123848652
Size: 38.93 MB
Format: PDF
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Statistics in Medicine, Third Edition makes medical statistics easy to understand by students, practicing physicians, and researchers. The book begins with databases from clinical medicine and uses such data to give multiple worked-out illustrations of every method. The text opens with how to plan studies from conception to publication and what to do with your data, and follows with step-by-step instructions for biostatistical methods from the simplest levels (averages, bar charts) progressively to the more sophisticated methods now being seen in medical articles (multiple regression, noninferiority testing). Examples are given from almost every medical specialty and from dentistry, nursing, pharmacy, and health care management. A preliminary guide is given to tailor sections of the text to various lengths of biostatistical courses. User-friendly format includes medical examples, step-by-step methods, and check-yourself exercises appealing to readers with little or no statistical background, across medical and biomedical disciplines Facilitates stand-alone methods rather than a required sequence of reading and references to prior text Covers trial randomization, treatment ethics in medical research, imputation of missing data, evidence-based medical decisions, how to interpret medical articles, noninferiority testing, meta-analysis, screening number needed to treat, and epidemiology Fills the gap left in all other medical statistics books between the reader’s knowledge of how to go about research and the book’s coverage of how to analyze results of that research New in this Edition: New chapters on planning research, managing data and analysis, Bayesian statistics, measuring association and agreement, and questionnaires and surveys New sections on what tests and descriptive statistics to choose, false discovery rate, interim analysis, bootstrapping, Bland-Altman plots, Markov chain Monte Carlo (MCMC), and Deming regression Expanded coverage on probability, statistical methods and tests relatively new to medical research, ROC curves, experimental design, and survival analysis 35 Databases in Excel format used in the book and can be downloaded and transferred into whatever format is needed along with PowerPoint slides of figures, tables, and graphs from the book included on the companion site, http://www.elsevierdirect.com/companion.jsp?ISBN=9780123848642 Medical subject index offers additional search capabilities