摘要
Ⅰ期临床试验主要关心药物的毒性,目的是在给定的剂量水平中寻找最大耐受剂量(MTD).本文提出了基于药物毒性反应等级的up-and—down自适应设计,调查了该设计在各种变化的剂量-毒性关系下的运作特征.结果表明:该设计方法对提高建议MTD的精确度,以及保护病人,防止病人暴露在较高毒性剂量下方面,对Ⅰ期临床试验的设计实现了有意义的改善.
One of the primary objectives of a phase Ⅰ study is to evaluate toxicity at different dose levels and recommend the maximum tolerated dose （MTD）. We give an up-and-down adaptive designs based on graded toxicity response. Through a lot of simulations, it shows that the design has improved the accuracy of recommending MTD. It apparently protects patients efficiently and prevents patients from excessive trials under the higher toxicity dose level and makes a great signficance in phase Ⅰ clinical trials design.
出处
《生物数学学报》
CSCD
北大核心
2008年第3期549-556,共8页
Journal of Biomathematics
基金
国家自然科学基金(10371005)
教育部优秀青年教师基金(VE00074)
北京市学术创新团队基金
