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 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.
Los Angeles County - University of Southern California Medical Center, Los Angeles, California, USA.|Department of Medicine, Keck School of Medicine at University of Southern California Medical Center, Los Angeles, California, USA.
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Spellberg
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
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Marr
Department of Medicine, David Geffen School of Medicine at the University of California - Los Angeles, Los Angeles, California, USA.
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Brass
D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D006801:Humans; D012106:Research / Q000592:standards; D012107:Research Design; D035501:Uncertainty; D014481:United States; D014486:United States Food and Drug Administration
D000890:Anti-Infective Agents