Practical exploration of ethical review in decentralized drug clinical trials
10.12026/j.issn.1001-8565.2025.01.06
- VernacularTitle:去中心化药物临床试验伦理审查的实践探索
- Author:
Xu ZUO
1
;
Yingshuo HUANG
1
;
Yue LI
1
;
Lihan XING
1
;
Chunxiu YANG
2
;
Yan CUI
2
Author Information
1. Department of Science and Technology， Beijing Friendship Hospital Affiliated to Capital Medical University， Beijing 100050， China
2. Office of the Drug Clinical Trial Institutions， Beijing Friendship Hospital Affiliated to Capital Medical University， Beijing 100050， China
- Publication Type:Journal Article
- Keywords:
decentralization;
drug clinical trial;
ethical review;
right and interest of subjects
- From:
Chinese Medical Ethics
2025;38(1):40-45
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials， promote clinical trial progress， and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials， analyzing the advantages and challenges of decentralized drug clinical trials， and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review， and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility， applicability， and rationality， the adequacy of informed consent， the protection of rights and interests and privacy of subjects， as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties， pay attention to the rights and interests of subjects， and gradually promote the implementation of decentralized drug clinical trials.
