摘要
目的介绍国外新提出的1期临床试验设计方法--键盘设计(keyboard design)模型、试验流程及其操作性能,为国内1期临床试验设计提供新方法。方法举例对键盘设计进行介绍,并通过模拟研究对键盘设计、mTPI设计及3+3设计进行比较。结果键盘设计在确定最大耐受剂量的精确性及安全性上优于mTPI设计。结论键盘设计操作简单,性能优越,是一种科学、可靠、灵活安全的1期临床试验设计方法。
Objective To introduce the model and test procedure and operation performance of keyboard design, a new phase 1 clinical trial method from abroad, and to provide reference for phase 1 clinical trials in China. Methods The keyboard design was introduced by examples. We compared among keyboard design, mTPI design and 3 + 3 design respecitvely. Results Keyboard design was superior to mTPI design as to security and accuracy of determination maximum tolerated dose. Conclusion Keyboard design has simple operation and good performance, which is a scientific, reliable, safe and flexible method of phase 1 clinical trials.
作者
郝肖迪
孙瑞华
沈庆
虞康达
吴婉玲
肖畅
王蜜源
HAO Xiao-di;SUN Rui-hua;SHEN Qing;YU Kang-da;WU Wan-ling;XIAO Chang;WANG Mi-yuan(Beijing University of Chinese Medicine,Beijing 100029;China-Japan Friendship Hospital,Beijing 100029)
出处
《中南药学》
CAS
2019年第6期851-854,共4页
Central South Pharmacy
关键词
键盘设计
1期临床试验
最大耐受剂量
keyboard design
phase 1 clinical trial
maximum tolerated dose
