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

B. Spellberg; K. A. Marr; E. P. Brass

doi:10.1002/cpt.510

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

B. Spellberg, K. A. Marr, E. P. Brass

School of Medicine

Research output: Contribution to journal › Comment/debate › peer-review

3 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	597-599
Number of pages	3
Journal	Clinical pharmacology and therapeutics
Volume	100
Issue number	6
DOIs	https://doi.org/10.1002/cpt.510
State	Published - Dec 1 2016

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.1002/cpt.510

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abstract = "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.",

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

Abstract

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