Current status and challenges of clinical trial registration from an ethical perspective
10.12026/j.issn.1001-8565.2026.10.06
- VernacularTitle:基于伦理视角探讨临床试验注册现状与挑战
- Author:
Shengmei ZHAO
1
;
Zhi WANG
1
;
Qin LAN
1
;
Tianhong WANG
1
;
Fang LIU
1
;
Lei CHEN
1
Author Information
1. Department of Clinical Research Management, West China Hospital of Sichuan University, Chengdu 610041, China
- Publication Type:Journal Article
- Keywords:
clinical trial;
clinical trial registration;
ethical review;
transparency;
research participants’ rights and interests
- From:
Chinese Medical Ethics
2026;39(10):1322-1329
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trial registration, as a cornerstone for transparency in medical scientific research, aims to systematically and comprehensively disclose key information such as trial design and implementation protocols before trial initiation. This reduces selective reporting and outcome bias, avoids unnecessary duplicate research, thereby protects research participants’ legitimate rights and interests and ethical compliance, and ultimately upholds research integrity and public trust. However, despite the widespread international recognition of its importance and necessity, registration practices worldwide still exhibit significant disparities. From an ethical perspective, this paper deeply analyzed the current status of clinical trial registration and the challenges it confronted, including issues such as insufficient awareness of prospective registration, inconsistent registration standards, persistent difficulties in data openness, sharing, and result disclosure, as well as imbalanced global governance of registration. It further explored multi-dimensional paths involving institutional coordination, technological empowerment, global collaboration, and ethical guidance, to promote clinical trial registration to realize full-cycle closed-loop management from registration and implementation to result reporting. These will provide solid theoretical support and practical references for establishing a more ethically resilient, highly transparent, and sustainably operational clinical trial registration system.