Noninferiority testing in clinical trials : issues and challenges

Noninferiority testing in clinical trials issues and challenges

"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 al...

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Bibliographische Detailangaben
1. Verfasser: Ng, Tie-Hua (VerfasserIn)
Format: UnknownFormat
Sprache:eng
Veröffentlicht: Boca Raton u.a. CRC Press 2015
Schriftenreihe:Chapman & Hall/CRC biostatistics series 68
Schlagworte:
Data Interpretation, Statistical > Controlled Clinical Trials as Topic / methods > Therapeutic Equivalency
Online Zugang:Inhaltsverzeichnis
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Beschreibung
Zusammenfassung:"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
Beschreibung:Includes bibliographical references and index
Beschreibung:XVII, 190 S. : Ill., graph. Darst.
ISBN:9781466561496