抗癌药Ⅰ期临床试验连续重评估方法及R软件实现

抗癌药Ⅰ期临床试验连续重评估方法及R软件实现

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:2019-06-21 修回日期:2019-06-21 出版日期:2019-08-28 发布日期:2019-08-28

R Statistical Software in the Application of Continual Reassessment Method for Phase Ⅰ Clinical Trial of Anti-cancer Drug

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:2019-06-21 Revised:2019-06-21 Online:2019-08-28 Published:2019-08-28

摘要/Abstract

摘要： 介绍了抗癌药Ⅰ期临床试验连续重评估方法（Continual reassessment method，CRM）的原理与实施步骤，以单骨架CRM为例，详细阐述了其在R软件中的实现方法，旨在为我国抗癌药Ⅰ期临床试验研究者和申办方提供生物统计学支持及技术参考。

黄亚芳,谢文杰. 抗癌药Ⅰ期临床试验连续重评估方法及R软件实现[J]. .

HUANG Ya-fang and. R Statistical Software in the Application of Continual Reassessment Method for Phase Ⅰ Clinical Trial of Anti-cancer Drug[J]. .

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