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

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.

SUBMITTER: Spellberg B

PROVIDER: S-EPMC5242400 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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

Spellberg B B Marr K A KA Brass E P EP

Clinical pharmacology and therapeutics 20161014 6

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 c ...[more]

PMID: 27626768

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