抗癌药Ⅰ期临床试验中的拓展性队列研究解析

The Expansion Cohort Study in Phase Ⅰ Trial for Anti-cancer Drug-the Conception and Analysis of its Application

通过阐述传统Ⅰ期临床试验在抗癌创新药临床研究中的局限性,归纳并剖析最新的拓展性队列试验的定义、目的和特征,梳理该拓展性队列试验设计的应用范围和注意事项,旨在为我国抗癌创新药临床试验设计方法学提供参考。

This article show the limitations of traditional phase I trial in development of novel anti-cancer drug,analyze and summarize the definition,objective and characteristic of expansion cohort trial,interpret the applications and consideration of expansion cohort trial.We hope it can help to provide methodological insight into the use of expansion cohort for anti-cancer drug development in our country.