在国外西药新药研发快速发展的今天,中药新药研发路径的选择问题变得迫切需要解决。探索性临床试验的“探索”理念,即在正式的临床试验前进行已开展动物实验的人体验证试验,为中药研发提供了新思路。但是,鉴于中药与西药的研发背景不同,中药不适合照搬其研究模式,而应建立自己的早期临床评价体系。 In the rapid development of foreign drug discovery and development in western countries today, the issue of the choice of new drug research and development path of Chinese medicine has become an urgent need to be resolved. The exploratory concept of exploratory clinical trials, that is, the human test that has carried out animal experiments before formal clinical trials, provides a new idea for the research and development of traditional Chinese medicines. However, given the different background of research and development of traditional Chinese medicine and western medicine, traditional Chinese medicine is not suitable for copying its research model, but should establish its own early clinical evaluation system.