Testing for non-inferior mortality: a systematic review of non-inferiority margin sizes and trial characteristics.
Sandra PongMartin UrnerRobert A FowlerNicholas MitsakakisWinnie SetoJames S HutchisonMichelle ScienceNick DanemanPublished in: BMJ open (2021)
Absolute and relative non-inferiority margins used in published trials comparing medications are large, allowing conclusions of non-inferiority in the context of large differences in mortality. Accepting the potential for large increases in outcomes involving mortality while declaring non-inferiority is a challenging methodological issue in the conduct of non-inferiority trials.