Exploration of practice of full-process Decentralized Clinical Trial
10.3760/cma.j.cn113565-20240314-00077
- VernacularTitle:全程去中心化临床试验的实践探索与思考
- Author:
Geliang YANG
1
;
Shuqin HU
1
Author Information
1. 上海医药临床研究中心 200032
- Publication Type:Journal Article
- Keywords:
Decentralized clinical trial;
Telemedicine;
Electronic informed consent
- From:
Chinese Journal of Medical Science Research Management
2024;37(6):502-506
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aims to explore the full-process Decentralized Clinical Trial (DCT) practice mode outsides traditional trial spots, as DCT is gradually applied to the recruitment and follow-up of research participants.Methods:Based on theoretical research and practical experience in Europe and the United States, combined with relevant guiding principles and expert consensus in China, the practice and experience of several full-process DCTs conducted by our team were summarized in recent years.Results:The key practical points of full-process DCTs, such as range, ethical review, research implementation, data management, research administration, and remote monitoring were analyzed.Conclusions:DCT mode is an important trend in the future development of clinical research. However, the current practice of full-process DCT is far from enough. On the one hand, it is necessary to promote the continuous improvement of relevant policies and systems. On the other hand, it is necessary to strengthen practical exploration and experience accumulation.
