Safety evaluation of anti-tumor drugs during early clinical trials
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.
clinical trialspharmacovigilanceadverse drug reactionanti-tumor drugs
NETL
NSTL
万方数据
