分散式临床试验在真实世界中的应用及探讨

doi:10.12114/j.issn.1007-9572.2024.0550

摘要/Abstract

摘要： 传统集中式临床研究常面临地理限制、参与者缺乏多样性和后勤挑战等障碍，在数字健康空前发展背景下，现代分散式（去中心化）临床试验（DCT）是临床研究的创新方法。DCT利用数字技术和真实世界环境提高了临床研究的包容性和可及性，简化试验流程，降低成本，使"以患者为中心"的理念在临床研究中得以实践，并能提供有较好外推性和可靠性的临床证据。本文介绍了DCT国内外发展历程、与传统临床研究的异同、展现的优势及实际应用，在此基础上，探讨了DCT实施面临的挑战及对策。

关键词: 分散式临床试验, 去中心化, 真实世界, 数字健康, 远程医疗

Abstract:

While traditional centralized clinical studies often face barriers such as geographic constraints, lack of participant diversity, and logistical challenges, modern decentralized clinical trials (DCT) are an innovative approach to clinical research that leverages digital health technologies and real-world environments to improve inclusiveness and accessibility of clinical research, streamline trial process, reduce costs, put "patient-centeredness" into practice in clinical research, and provide clinical evidence with good extrapolation and reliability. This paper introduces the development history of DCT at home and abroad, the similarities and differences between DCT and traditional clinical research, the advantages and challenges, on the basis, discusses the prospects for the application of DCT in the real world.

Key words: Decentralized clinical trials, Decentralization, Real world, Digital health, Telemedicine

中图分类号:

刘嘉玲,班承钧. 分散式临床试验在真实世界中的应用及探讨[J]. 中国全科医学, 2026, 29(14): 1946-1952. DOI: 10.12114/j.issn.1007-9572.2024.0550.
LIU Jialing,BAN Chengjun. An Exploration of Decentralized Clinical Trials in the Real World[J]. Chinese General Practice, 2026, 29(14): 1946-1952. DOI: 10.12114/j.issn.1007-9572.2024.0550.

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