早期临床试验期间抗肿瘤治疗药物安全性评估  

Safety evaluation of anti-tumor drugs during early clinical trials

作　　者：胡文娟 杜瑜 唐凌 杨志敏 HU Wen-juan;DU Yu;TANG Ling;YANG Zhi-min(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2024年第20期2114-2118,共5页Chinese Journal of New Drugs

摘　　要：为提高抗肿瘤药物早期临床试验期间安全性风险评估的质量,本文梳理了近2年药品监管机构收到的抗肿瘤药物临床研发期间非预期严重不良反应以及临床研发期间安全性更新报告,结合目前ICH E2A的相关要求以及国内外的早期临床试验中、高风险如暂停或终止临床试验等案例,对于安全性风险评估的共性问题进行总结并给予风险识别、评估和处理建议。从事抗肿瘤药物临床试验的药物警戒相关人员应重视早期临床试验的风险识别和评估,以更好地保护受试者的安全。In order to improve the quality of safety risk assessment during the early clinical trials of anti-tumor drugs,the unexpected serious suspected adverse reactions and safety update reports during the clinical research and development of anti-tumor drugs received by the regulatory authorities in the past two years were sorted out.Based on the current relevant requirements of ICH E2A,as well as the high-risk cases in the early clinical trials at home and abroad,such as suspension or termination of clinical trials,the common problems of safety risk assessment were summarized,and suggestions for risk identification,assessment and treatment were given.Personnel engaged in the pharmacovigilance of anti-tumor drug research and development should pay attention to the risk identification and evaluation of early clinical trials to better protect the safety of subjects.

关 键 词：临床试验 药物警戒 不良反应 抗肿瘤药物 

分 类 号：R969.4[医药卫生—药理学]