Noninferiority testing in clinical trials
Subtitle: issues and challenges
By: Tie-Hua Ng
Series: Chapman & Hall/CRC biostatistics series; Chapman & Hall/CRC biostatistics series (Unnumbered)
Publisher: Taylor & Francis/CRC Press; Chapman and Hall/CRC
Published: 2015
Place of publication: Boca Raton
Language: eng
Number of pages: 190
ISBN-13: 9781466561496
Subjects: Controlled Clinical Trials as Topic; Methods; Statistical Data Interpretation; Therapeutic Equivalency
Description: "This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups"--Provided by publisher.
Notes: Includes bibliographical references and index.