摘要
本文通过回顾性分析美国FDA首次批准上市的抗肿瘤靶向药物早期临床研究设计和临床研发策略的特点及趋势,为抗肿瘤靶向新药的早期临床研究设计和临床研发策略的制定提供参考。通过分析2001年1月1日—2017年5月30日期间美国FDA首次批准上市的62个抗肿瘤靶向新药的相关数据,从首次人体试验适应证人群的选择、研究设计、药政申报策略3个角度进行回顾性分析。通过对上述数据的分析,总结出抗肿瘤靶向新药早期临床研究设计与临床研发策略的共性与趋势,并就研究结果对于中国肿瘤创新药的早期开发的意义做阐述。
This paper analyzes retrospectively the characteristics and trends of the design of early clinical trials and clinical development strategies of targeted anticancer drugs which were first approved by the FDA,to provide reference for researchers in this field so as to make more effective targeted anticancer drugs available for clinical therapy faster. The targeted anticancer drugs which were first approved by FDA from January 1 st 2001 to May 30 th 2017 were included in this study. Data analysis was carried out from three aspects: selection of target population,study design,and drug policy declaration strategy. Through analyzing the above data the authors summarized the commonness and tendency of the design of early clinical trials and clinical research development strategy of targetd anticancer drugs and expounded the significance of the research results on early development of innovative anticancer drugs in China.
作者
秦璐
刘水
赵娣
刘川
周发俊
QIN Lu;LIU Shin;ZHAO Di;LIU Chuan;ZHOU Fa-jun(School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211100,China;Beijing Clinical Service Center,Shanghai 200000,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第2期129-134,共6页
Chinese Journal of New Drugs
关键词
抗肿瘤靶向药物
早期临床试验
研究设计
研发策略
anticancer targeted agents
early clinical trial
study design
drug development strategy
