Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?

Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0162721. doi: 10.1128/AAC.01627-21. Epub 2021 Oct 18.

Abstract

Noninferiority randomized controlled trial (RCT) effectiveness may erode when results favor 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 noninferiority trials is uncommon. Findings are limited by small sample size and overall risk of bias.

Keywords: anti-infective agents; antifungal agents; biocreep; noninferiority trials; systematic review.

Publication types

  • Systematic Review

MeSH terms

  • Antifungal Agents* / therapeutic use
  • Randomized Controlled Trials as Topic

Substances

  • Antifungal Agents