• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

• 药品评价-临床研究 • 上一篇    下一篇

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   

  1. 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   

  1. 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: 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。

Abstract: We introduced the principles and steps of continual reassessment method (CRM) for phase I clinical trial design of anti-cancer drugs and presented in detail about the conducting and assessing of CRM design based on single skeleton using R package, thus aimed to provide to clinicians and sponsors biostatistical support and technological reference for their phase I clinical trial of anti-cancer drugs in China.