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Regulatory Pathways for New Antimicrobial Agents: Trade‐offs to Keep the Perfect From Being the Enemy of the Good
Author(s) -
Spellberg B,
Marr KA,
Brass EP
Publication year - 2016
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.510
Subject(s) - antimicrobial , adversary , biology , computer science , microbiology and biotechnology , computer security
In 2002, Shlaes and Moellering warned that pharmaceutical companies were abandoning antibiotic research and development due to changing regulatory standards regarding noninferiority (NI) clinical trials. NI trials are subject to unique biases that may yield false‐positive conclusions. The US Food and Drug Administration (FDA) developed guidance to ensure that NI results truly reflect drug efficacy. These changes, intended to reduce uncertainty in trial results, have shaped trial enrollment and conduct in ways that now require reflection.