Choice of non-inferiority (NI) margins does not protect against degradation of treatment effects on an average--an observational study of registered and published NI trials.

OBJECTIVE:NI margins have to be chosen appropriately to control the risk of degradation of treatment effects in non-inferiority (NI) trials. We aimed to study whether the current choice of NI margins protects sufficiently against a degradation of treatment effect on an average. STUDY DESIGN AND SETT...

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Bibliographic Details
Main Authors: Beryl Primrose Gladstone, Werner Vach
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2014-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4117500?pdf=render