Pay attention to the safety of healthy volunteers in clinical trials
10.3760/cma.j.cn114015-20220606-00495
- VernacularTitle:重视健康受试者参与临床试验的安全性
- Author:
Duanduan CONG
1
;
Wei XUE
;
Xiaohui LIU
;
Kexin LI
;
Xin HU
Author Information
1. 北京医院临床试验研究中心/国家老年医学中心/中国医学科学院老年医学研究院，北京 100730
- Publication Type:Journal Article
- Keywords:
Healthy volunteers;
Safety;
Risk management;
Clinical trials
- From:
Adverse Drug Reactions Journal
2022;24(6):281-283
- CountryChina
- Language:Chinese
-
Abstract:
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.
