摘要
结合审评实践和国外相关技术指南,初步探讨了新药从非临床过渡进入到早期临床试验时的风险识别和风险控制策略。分析了早期临床试验的潜在风险影响因素,阐明了风险识别的关注要点,并就临床试验风险控制策略和试验关键设计给出了建议,以期为新药研究者提供参考。
The strategies to identify and mitigate risks in the transition from non-clinical to early clinical trials were preliminary discussed in combination with our review practice and related technical guidelines abroad.The potential risk factors of early clinical trials were comprehensively analyzed,the concerns of risk identification were clarified,and the recommendations for risk management strategies and key designs of clinical trials were provided,so as to provide references for investigators.
作者
戴学栋
王庆利
孙涛
DAI Xue-dong;WANG Qing-li;SUN Tao(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第18期2060-2065,共6页
Chinese Journal of New Drugs
关键词
首次临床试验
早期临床试验
风险识别
风险控制
first-in-human
early clinical trials
risk identification
risk mitigation
