中华医学科研管理杂志2024,Vol.37Issue(6) :502-506.DOI:10.3760/cma.j.cn113565-20240314-00077

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

杨葛亮 胡舒勤
中华医学科研管理杂志2024,Vol.37Issue(6) :502-506.DOI:10.3760/cma.j.cn113565-20240314-00077

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

杨葛亮 1胡舒勤1
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作者信息

  • 1. 上海医药临床研究中心 200032
  • 折叠

摘要

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.

Abstract

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.

关键词

去中心化临床试验/远程医疗/电子知情同意

Key words

Decentralized clinical trial/Telemedicine/Electronic informed consent

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出版年

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
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