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 inClinical pharmacology and therapeutics Vol. 100; no. 6; p. 597
Main Authors Spellberg, B, Marr, K A, Brass, E P
Format Journal Article
LanguageEnglish
Published United States 01.12.2016
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:1532-6535
DOI:10.1002/cpt.510