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全程去中心化临床试验的实践探索与思考

Exploration of practice of full-process Decentralized Clinical Trial

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目的 在去中心化临床试验(DCT)模式已逐步应用于研究参与者的招募和随访等背景下,探索在传统试验场所以外开展全程DCT的实践模式.方法 在分析欧美国家的理论研究、实践基础上,结合我国相关指导原则、专家共识,对笔者团队近年来开展过的多项全程DCT的实践和经验进行总结.结果 深入探讨了全程DCT的适用范围、伦理审查、研究实施、数据管理、研究管理及远程监查等实践要点,并进行经验分享.结论 DCT模式是今后临床研究发展的重要趋势,然而,目前全程DCT的实践远远不够.一方面要推进相关政策与制度不断完善,另一方面要加强实践探索及经验积累.
Objective This study aims to explore the full-process Decentralized Clinical Trial(DCT)practice mode out-sides 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 princi-ples and expert consensus in China,the practice and experience of several full-process DCTs conducted by our team were sum-marized in recent years.Results The key practical points of full-process DCTs,such as range,ethical review,research imple-mentation,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 e-nough.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.

Decentralized clinical trialTelemedicineElectronic informed consent

杨葛亮、胡舒勤

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上海医药临床研究中心 200032

去中心化临床试验 远程医疗 电子知情同意

2024

中华医学科研管理杂志
中华医学会

中华医学科研管理杂志

CSTPCD
影响因子:0.515
ISSN:1006-1924
年,卷(期):2024.37(6)