欧盟医药管理局对新抗菌药物临床试验策略和设计的考虑

EMEA's consideration on strategy and design of clinical trials for new antibacterial agent

试验设计是临床试验能否获得成功的关键。本文简要介绍了欧盟医药管理局对抗菌药物临床试验策略和设计的相关考虑,希望对我国创新性抗菌药物的临床试验设计和评价有所提示和参考。

Design is the key point of clinical trials. This article is to introduce EMEA＇ s （ European Medicines Agency, EMEA） consideration on strategy and design of clinical trials for new antibacterial agent, hoping to give some reference to design and evaluation of clinical trials for new antibacterial agent in China.