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

• Published in: Clinical pharmacology and therapeutics Vol. 100; no. 6; p. 597
• Main Authors: Spellberg, B, Marr, K A, Brass, E P
• Format: Journal Article
• Language: English
• 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

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...