Practice suggestions for decentralized clinical trials in China under the new situation
10.3969/j.issn.1671-332X.2025.04.009
- VernacularTitle:新形势下我国去中心化临床试验的实践建议
- Author:
Kexuan JIANG
1
;
Qingshu LIN
;
Jiyin ZHOU
Author Information
1. 中国人民解放军陆军第八十集团军医院 山东潍坊 261042
- Publication Type:Journal Article
- Keywords:
Decentralized clinical trials;
New situation;
China;
Suggestions
- From:
Modern Hospital
2025;25(4):524-528
- CountryChina
- Language:Chinese
-
Abstract:
Decentralized clinical trials(DCT)must adhere to the core concept of"patient-centered".DCT has many advantages,such as faster recruitment of diverse study participants,lower participation costs,increased compliance,friendliness to study participants,electronic informed consent,expedited investigational medical product delivery,and convenient data collec-tion.DCT in China faces new requirements for both clinical trial institutions and medical services,inadequate support for infor-mation systems,compliance with electronic informed consent,higher requirements for data security and personal information pro-tection,and the need for multiple training,and other challenges.To accelerate the implementation of DCT in China,the author believes that the following measures can be taken,such as strengthening the construction of information infrastructure to facilitate the participation of grassroots medical institutions and data collection of study participants;establishing communication channels and strengthening training;carefully designing the protocol,establishing standard operating procedures for clinical trials,and strengthening ethical review;conducting remote safety monitoring and reporting safety information;clarifying the data reporting procedure and obtaining high-quality trial data through data collection and management.
