Consideration of Ethical Protection in Drug Clinical Trials for Rare Diseases in Children
10.12026/j.issn.1001-8565.2022.05.05
- VernacularTitle:儿童罕见病药物临床试验伦理保护的思考
- Author:
Hui ZHANG
1
;
Xiaohong LIU
1
;
Yonghua YANG
1
Author Information
1. Department of Pediatrics, the First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China
- Publication Type:Journal Article
- Keywords:
Rare Diseases in Children;
Ethical Protection;
Drug Clinical Trials
- From:
Chinese Medical Ethics
2024;35(5):494-498
- CountryChina
- Language:Chinese
-
Abstract:
Children with rare disease belong to a vulnerable group. When China’s current medical security system cannot provide comprehensive health care, they not only face physical and mental torture, but also have a higher risk of children participating in clinical trials than adults. So, adequate protection of children’s safety and rights is the key to ethical review. This paper analyzed the current status of drugs clinical trials for rare disease in children, including trial difficulties and guarantee system; explained the ethical principles that should be followed in clinical trials, such as the principle of informed consent and the principle of no harm; and discussed the path of protecting children’s safety and rights, so as to raise awareness and attention of the importance of ethical review of clinical trials.
