美国FDA对抗菌药物临床试验非劣效设计的考虑

FDA's considerations of non-inferiority design used in anti-bacterial drug clinical trials

本文介绍了美国食品药品监督管理局关于抗菌药物临床试验非劣效设计的考虑。如有足够证据证明,阳性对照药明确的有效性,采用非劣效性设计可能是合适的;所提出的非劣效性界值应有充分的依据。

This article is to introduce FDA＇ s （Food and Drug Administration, FDA） considerations of noninferiority design used in anti - bacterial drug clinical trial. Non - inferiority study designs may be appropriate when there is adequate evidence of a defined effect size for the control treatment, so that the proposed noninferiority margin can be supported.