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文章摘要
HUANG Ya-fang.R Statistical Software in the Application of Continual Reassessment Method for Phase Ⅰ Clinical Trial of Anti-cancer Drug[J].中国药物评价,2019,36(4):294-299
抗癌药Ⅰ期临床试验连续重评估方法及R软件实现
R Statistical Software in the Application of Continual Reassessment Method for Phase Ⅰ Clinical Trial of Anti-cancer Drug
投稿时间:2019-06-21  修订日期:2019-06-21
DOI:
中文关键词: Ⅰ期试验  抗癌药  连续重评估方法  R软件  贝叶斯统计
英文关键词: Phase Ⅰ trial  Anti-cancer drug  Continual reassessment method  R statistical software  Bayesian statistics
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作者单位E-mail
黄亚芳 首都医科大学全科医学与继续教育学院 huangyafang85@163.com 
谢文杰 临床研究部,伯尔尼大学小岛医院,瑞士  
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中文摘要:
      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。
英文摘要:
      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.
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