关于脊髓型颈椎病复方中药新药临床试验设计的考虑

Thoughts on clinical trial design of new compound Chinese medicine for cervucal spondylofic myelopathy

基于近期脊髓型颈椎病的中药新药审评工作的思考,对该适应证中药新药临床研究设计的关键问题进行探讨。本文重点从临床定位、诊断标准、受试者的选择、疗程设计、安全性风险的控制、疗效评价等方面对临床研究中需关注的问题进行具体说明。

Based on the thoughts about the evaluation of new drug of compound traditional Chinese medicine for cervical spondylofic myelopathy recently,this article made the preliminary study on the key points of the clinical trial design of traditional Chinese medicine new drug,and also elaborated on clinical orientation,diagnostic criteria,the choice subjects,treatment course,safety index design,validity evaluation of the clinical trials.