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The ABC of non‐inferiority margin setting from indirect comparisons
Author(s) -
Julious Steven A.
Publication year - 2011
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.517
Subject(s) - placebo , bayesian probability , assay sensitivity , population , margin (machine learning) , placebo response , medicine , minimisation (clinical trials) , econometrics , statistics , computer science , mathematics , machine learning , alternative medicine , environmental health , pathology
In a non‐inferiority trial to assess a new investigative treatment, there may need to be consideration of an indirect comparison with placebo using the active control in the current trial. We can, therefore, use the fact that there is a common active control in the comparisons of the investigative treatment and placebo. In analysing a non‐inferiority trial, the ABC of: A ssay sensitivity, B ias minimisation and C onstancy assumption needs to be considered. It is highlighted how the ABC assumptions can potentially fail when there is placebo creep or a patient population shift. In this situation, the belief about the placebo response expressed in terms of a prior probability in Bayesian formulation could be used with the observed treatment effects to set the non‐inferiority limit. Copyright © 2011 John Wiley & Sons, Ltd.