复发性阿弗他溃疡新药临床试验设计的考虑

Thoughts on clinical trial design of new drugs for recurrent aphthous ulcer

基于近期复发性阿弗他溃疡新药临床试验技术审评工作的思考,对该适应症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、对照药的选择、疗程设计、合并治疗及用药、终点指标设计、日志卡的设置、质量控制等方面对临床试验中需关注的问题进行具体说明。

Based on the thoughts about the evaluation of new drug for recurrent aphthous ulcer recently,this article made the preliminary study on the key points of the clinical trial design of new drug,and also elaborated on clinical orientation,diagnostic criteria,the choice subjects,control drug selection,treatment course,combined treatment and medication,validity evaluation of the clinical trials,patient diary card setting,the quality control.