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
Rezensionen / Stimmen
"The author gives interesting examples and discusses all issues critically with respect to existing literature. Furthermore, striking and convincing motivation is given as well as discussions at the ends of most chapters. Many diagrams and graphs clearly illustrate the respective content and statistical issues. The book allows readers from different fields to understand the concept of NI testing as well as issues and challenges related to NI testing."
~Biometrics, 2017
"This book is intended for statisticians and non-statisticians working in the area of drug development, and it is written to be easily understood by a broad audience without any prior knowledge of non-inferiority testing. It covers important aspects of non-inferiority testing, including onesided and two-sided hypotheses, equivalence/non-inferiority margins, fixed-margin and the synthesis methods, controversial issues with switching between superiority and non-inferiority testing, tests with binary, continuous and time-to-event endpoints, multiple historical studies and meta-analysis, regulatory guidances, and issues and challenges in these tests."
~Lili Zhao, University of Michigan
Reihe
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für höhere Schule und Studium
Statisticians and clinicians involved in the design, conduct, and analysis of noninferiority trials.
Illustrationen
24 s/w Abbildungen, 16 s/w Tabellen
24 b/w images, 16 tables and approx 17 equations
Dateigröße
ISBN-13
978-1-4665-6150-2 (9781466561502)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Introduction. Choice of Noninferiority Margin for the Mean Difference. Choice of Noninferiority Margin for the Mean Ratio and Hazard Ratio. Noninferiority Hypotheses with Binary Endpoints. Two Statistical Approaches for Testing the Noninferiority Hypothesis. Switching between Superiority and Noninferiority. Multiple Historical Studies and Meta-Analysis. Three Treatment Groups. Regulatory Guidances. Intention-to-Treat versus Per-Protocol. Thrombolytic Example. Issues and Challenges. Index.
