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中国临床试验从业者对去中心化临床试验的认知、实践与态度研究。

Study on knowledge, practices, and attitudes toward decentralized clinical trials among the clinical trial practitioners in China.

作者信息

Shi Yuanyuan, Bao Yujian, Pu Yu, Jiang Junhao, Yan Bo, Zheng Hang

机构信息

School of Pharmacy, Chongqing Medical University, Chongqing, China.

Medical Imaging Key Laboratory of Sichuan Province, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.

出版信息

Front Med (Lausanne). 2025 Apr 17;12:1513975. doi: 10.3389/fmed.2025.1513975. eCollection 2025.

Abstract

BACKGROUND

Studies on the application of decentralized clinical trials (DCTs) in China are limited. This study aimed to investigate the knowledge, practices, and attitudes of clinical trial practitioners in China toward DCTs.

METHOD

An anonymous cross-sectional study was conducted from November 1st to November 30th, 2023. A total of 621 valid questionnaires were collected, including 227 completed by Clinical Research Associates (CRAs), 150 by Clinical Research Coordinators (CRCs), and 244 by Program Managers (PMs).

RESULTS

The majority of respondents possessed basic knowledge of DCTs and showed a high willingness to participate, but their practice experience was limited, with a relatively high level of practice experience in internet recruitment. Respondents were more interested in the improvement of patients' rights brought by DCTs, such as more opportunities for clinical trials. Technical barriers and data reliability were the main barriers to implementation.

CONCLUSION

Clinical trial practitioners need to enhance their technical skills and knowledge about DCTs, enhance the overall level of the industry, and promote the better implementation and application of DCTs in China.

摘要

背景

关于分散式临床试验(DCTs)在中国应用的研究有限。本研究旨在调查中国临床试验从业者对DCTs的认知、实践情况及态度。

方法

于2023年11月1日至11月30日进行了一项匿名横断面研究。共收集到621份有效问卷,其中临床研究助理(CRAs)填写了227份,临床研究协调员(CRCs)填写了150份,项目经理(PMs)填写了244份。

结果

大多数受访者具备DCTs的基本知识并表现出较高的参与意愿,但其实践经验有限,在网络招募方面实践经验相对较高。受访者对DCTs带来的患者权利改善更感兴趣,如更多的临床试验机会。技术障碍和数据可靠性是实施的主要障碍。

结论

临床试验从业者需要提高他们关于DCTs的技术技能和知识,提升行业整体水平,促进DCTs在中国更好地实施和应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa63/12043678/f1e7ad0b7052/fmed-12-1513975-g001.jpg

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