Ⅰ期临床试验健康受试者剂量递增停止规则——法国Ⅰ期临床工作组意见介绍  

Dose escalation and stopping rules for healthy subjects in phaseⅠclinical trials,an introduction of points from French Club Phase Ⅰ working group

作　　者：杨光宇 钱薇[1] 肖大伟[1] YANG Guang-yu, QIAN Wei, XIAO Da-wei(Unit of Phase I Clinical Trail, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical College, Nanjing JIANGSU 210008, Chin)

机构地区：[1]南京大学医学院附属鼓楼医院Ⅰ期临床试验研究室,江苏南京210008

出　　处：《中国新药与临床杂志》2018年第3期143-147,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：在药物的首次人体试验(FIM)中,必须全面分析受试者的安全性数据后再谨慎决定药物剂量是否应继续递增。安全性数据中最重要的就是不良事件,目前我国健康受试者药物试验的不良事件分级标准仍有争议。本文介绍了法国Ⅰ期临床工作组(CPⅠ)的FIM不良事件分级标准,同时探讨剂量递增的规则,为同行们提供参考。Safety signals must be analyzed comprehensively before making dose escalation decisions in first-entry-into-man （FIM） studies. The most important safety datum is the adverse event, while there are still various arguments in grading scale criteria for healthy subjects in China. The article introduced the safety grading scale and dose escalation rules in FIM studies proposed by French Club Phase I working group （CP Ⅰ ） in order to offer reference for our colleagues.

关 键 词：临床试验 Ⅰ期 研究对象 安全 剂量递增 停止规则 

分 类 号：R95[医药卫生—药学]