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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。
This article is to introduce FDA's(Food and Drug Administration, FDA)considerations of non-inferiority design used in anti-bacterial drug clinical trial.
另外，对照的设立应结合考虑RCT研究的目的和设计，如非劣效性、等效性、优效性试验。
Besides, the selection of controls must focus on the design and aim of RCTs, such as non-inferiority, equivalence and superiority trials.
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