Spellberg B, Marr K A, Brass E P
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.
Clin Pharmacol Ther. 2016 Dec;100(6):597-599. doi: 10.1002/cpt.510. Epub 2016 Oct 14.
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.
2002年，施莱斯和莫勒林警告称，由于关于非劣效性（NI）临床试验的监管标准不断变化，制药公司正在放弃抗生素研发。NI试验存在可能产生假阳性结论的独特偏差。美国食品药品监督管理局（FDA）制定了指南，以确保NI结果能真正反映药物疗效。这些旨在减少试验结果不确定性的变化已经在影响试验入组和实施方式了，现在需要对此进行反思。
