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理解去中心化临床试验中期望与现实之间的差距。

Understanding the gap between expectations and reality in decentralized clinical trials.

作者信息

Jiang Yale, Leng Ye, Wu Qing, Hou Yiru, Dong Xueyuan, Zeng Caiwen, Wu Dawei, Fang Hong, Tang Yu, Huang Huiyao, Li Ning

机构信息

Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Clinical Medical Research Center, Jiangxi Cancer Hospital (The Second Affiliated Hospital of Nanchang Medical College), Nanchang, Jiangxi, China.

出版信息

NPJ Digit Med. 2025 Jul 4;8(1):408. doi: 10.1038/s41746-025-01811-y.

Abstract

Decentralized clinical trials (DCTs) have gained long-standing interest, yet their adoption as a new paradigm remains uncertain even with broader acceptance from regulatory and industry. This study aims to unveil its evolutional trend, which helps answer what the current development stage DCT is located at as well as the underlying reasons. While DCTs' prime time has not arrived, we propose solutions to advance their sustainable implementation.

摘要

去中心化临床试验(DCTs)长期以来一直备受关注,然而,即便得到了监管机构和行业更广泛的认可,其作为一种新范式被采用的情况仍不明朗。本研究旨在揭示其发展趋势,这有助于回答DCT目前处于何种发展阶段以及背后的原因。虽然DCT的黄金时代尚未到来,但我们提出了推进其可持续实施的解决方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a14f/12227689/45fdb3f8a656/41746_2025_1811_Fig1_HTML.jpg

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