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American Society for Microbiology, Antimicrobial Agents and Chemotherapy, 1(66), 2022

DOI: 10.1128/aac.01627-21

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

Journal article published in 2022 by Adam S. Komorowski ORCID, Anthony D. Bai ORCID, Anna Cvetkovic ORCID, Omar Mourad, Carson K. L. Lo ORCID, Xena X. Li ORCID, Vaibhav Mokashi ORCID, Aidan Findlater ORCID, D. Brody Duncan ORCID, Charlotte Fuller, Daniela L. Leto, Deborah Yamamura, Dominik Mertz ORCID
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Non-inferiority 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.