抗癌药I期临床试验中的拓展性队列研究解析

抗癌药I期临床试验中的拓展性队列研究解析

黄亚芳,谢文杰

首都医科大学全科医学与继续教育学院,临床研究部,伯尔尼大学小岛医院,瑞士

收稿日期:2018-10-07 修回日期:2018-11-01 出版日期:2018-12-25 发布日期:2018-12-25
基金资助:
北京市优秀人才项目(NO. 2016000020124G097)

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

HUANG Ya-fang and

School of General Practice and Continuing Education,Capital Medical University,Department Clinical Research,Inselspital,University of Bern,Murtenstrasse ,Bern,Switzerland

Received:2018-10-07 Revised:2018-11-01 Online:2018-12-25 Published:2018-12-25

摘要/Abstract

摘要： 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。

黄亚芳,谢文杰. 抗癌药I期临床试验中的拓展性队列研究解析[J]. .

HUANG Ya-fang and. The Expansion Cohort Study in Phase I Trial for Anti-cancer Drug-the Conception and Analysis of its Application[J]. .

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