我国创新性抗菌药物临床试验现状及发展的探讨

Discussion about current status and development of clinical trials for new antibacterial drugs in China

在整个药物研发过程中,创新性抗菌药物的临床试验占有非常重要的地位。本文对目前我国创新药临床试验现状进行探讨,并结合负责起草的新版《抗菌药物临床试验技术指导原则》的认知,展望未来发展方向,旨在促进研发与评价。

Clinical trial plays an important role in a new anti -bacterial drug research and development. Based on the analysis of situation of clinical trails in China and the experiences in drafting out new guidance for clinical trials of anti - bacterial drugs. Some suggestions are given to promot the new anti -bacterial drug development and evaluation in China.