重视健康受试者参与临床试验的安全性

Pay attention to the safety of healthy volunteers in clinical trials

由于健康受试者在临床试验中通常无预期的直接临床获益,因此结合其群体特征,在试验各个环节充分评估风险和开展安全性监测尤为重要。健康受试者参与临床试验的风险点存在于试验药物、临床试验设计和试验执行过程等方面,应通过落实药物警戒新规,提升风险管理水平,提高临床试验结果的透明度,以及开展相关的风险管理研究,更好地保障健康受试者的安全和权益。

Since healthy volunteers usually have no expected direct clinical benefits in clinical trial,it is particularly important to fully assess the risks and carry out safety monitoring in all links of the trial in combination with their group characteristics.The risk points for healthy volunteers to participate in clinical trials lie in the aspects of trial drugs,clinical trial design,and trial implementation process.The safety and rights of healthy volunteers should be better protected by implementing the Good Pharmacovigilance Practices,improving the level of risk management,enhancing the transparency of clinical trial results,and carrying out relevant risk management research.