Are antifungal non-inferiority trials at risk of eroding effectiveness because of bio-creep? A secondary analysis of a systematic review.

Abstract

Non-inferiority randomized controlled trial (RCT) effectiveness may erode when results favour the active control over time, and when a decreasingly effective control arm is used in serial trials. We analyzed 32 antifungal noninferiority RCTs (NI-RCTs) for these scenarios in this secondary analysis of a systematic review. Our exploratory analysis suggests that the erosion risk in the effectiveness of antifungal non-inferiority trials is uncommon. Findings are limited by small sample size, and overall risk of bias.