连续重评估方法无差异区间半宽度δ的校正与毒性概率估计

中国药物评价 ›› 2019, Vol. 36 ›› Issue (5): 397-400.

• 药物研究 • 上一篇

连续重评估方法无差异区间半宽度δ的校正与毒性概率估计

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

出版日期:2019-10-28 发布日期:2019-10-28

Half-width (δ) of Indifferent Interval and Toxicity Probabilities Calculation in Continual Reassessment Method

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

Online:2019-10-28 Published:2019-10-28

摘要/Abstract

摘要： 本文介绍了抗癌新药研发中Ⅰ期临床试验连续重评估方法（Continual reassessment method，CRM）中无差异区间半宽度δ的概念与校正方法。利用R软件，详细阐述了半宽度δ校正的实施步骤，最后，介绍了CRM毒性概率的生成方法和模型验证，旨在为今后我国抗癌新药研发Ⅰ期临床试验设计提供方法学支持。

关键词: 连续重评估方法, 无差异区间, 毒性概率, Ⅰ期试验, R软件

Abstract: We introduced the concept and calculation method of half-width (δ) of indifferent interval in continual reassessment method (CRM) for phase I clinical trial design of anti-cancer drugs. Using the R statistical software， we presented in detail about the calibration approach of half-width (δ). In the end， we introduced the approaches of toxicity probabilities calculation and model validation using R statistical software. We hope this article can provide methodological support for the design of phase Ⅰ clinical trial of anti-cancer drug for our country.

Key words: Continual reassessment method, Indifferent interval, Toxicity probabilities, Phase I trial, R statistical software

黄亚芳, 谢文杰. 连续重评估方法无差异区间半宽度δ的校正与毒性概率估计[J]. 中国药物评价, 2019, 36(5): 397-400.

参考文献

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连续重评估方法无差异区间半宽度δ的校正与毒性概率估计

Half-width (δ) of Indifferent Interval and Toxicity Probabilities Calculation in Continual Reassessment Method

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