Regulatory Pathways for New Antimicrobial Agents: Trade-offs to Keep the Perfect From Being the Enemy of the Good

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 an...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2016-12, Vol.100 (6), p.597-599
Main Authors: Spellberg, B, Marr, KA, Brass, EP
Format: Article
Language:English
Subjects:
Anti-Infective Agents - therapeutic use
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - methods
Clinical Trials as Topic - standards
Drug Industry - legislation & jurisprudence
Drug Industry - methods
Drug Industry - standards
Humans
Research - standards
Research Design
Uncertainty
United States
United States Food and Drug Administration
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Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.510