E-Book, Englisch, 208 Seiten
Ng Noninferiority Testing in Clinical Trials
Erscheinungsjahr 2014
ISBN: 978-1-4665-6150-2
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)
Issues and Challenges
E-Book, Englisch, 208 Seiten
Reihe: Chapman & Hall/CRC Biostatistics Series
ISBN: 978-1-4665-6150-2
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)
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.
Zielgruppe
Statisticians and clinicians involved in the design, conduct, and analysis of noninferiority trials.
Autoren/Hrsg.
Weitere Infos & Material
Equivalence/Noninferiority Testing in General. How to Determine NI Margin (Mean Difference for Continuous Endpoint). How to Determine NI Margin (Mean Ratio and Other Endpoints). Issues of Estimating the Effect Size. Two Statistical Approaches: Fixed Margin and Synthesis Methods. Issues of Switching between NI and Superiority. Other Topics. Examples.
