中国食品药品监管Issue(3)：70-81,12.DOI:10.3969/j.issn.1673-5390.2025.03.006
我国开展去中心化临床试验面临的主要风险和挑战及应对思考
Main Risks,Challenges,and Coping Strategies for Conducting Decentralized Clinical Trials in China
张晓方 1佟天琦 2徐岩 3孙婉 2武阳丰1
作者信息
- 1. 北京大学临床医学高等研究院,临床研究所 北大医学-中国生物临床与监管科学联合实验室
- 2. 北京大学临床医学高等研究院,临床研究所
- 3. 北京大学第三医院药物临床试验机构
- 折叠
摘要
Abstract
Objectives:This study aims to identify the main risks and challenges associated with the implementation of decentralized clinical trial(DCT)in China and provide recommendations for the healthy development of DCT.Methods:Representatives from various stakeholders in DCT were selected using a convenient sampling method,and qualitative interviews were conducted to collect data.The thematic framework method was employed to analyze the interview data.Results:There are significant differences in the usage frequency of DCT elements and in the understanding and practice of DCT among stakeholders.The main risks and challenges included:The current healthcare system's architecture and infrastructure do not meet the needs for DCT implementation;Clearer regulatory initiatives and policies are needed to provide support and guidance,as stakeholders remain concerned about unknown risks,and coordination among different regulatory authorities needs to be strengthened;Capacity building for stakeholders must be enhanced,and patients exhibit insufficient awareness and participation in clinical trials.Conclusion:It is recommended that the implementation of DCT be patient-focused and fit for purpose.A pilot approach should be adopted to generate a demonstration effect and cultivate a supportive environment for DCT in China.DCT elements with a solid implementation foundation and experience should be selected as breakthrough points,and industry standards or regulatory guidance should be issued for these elements to promote their development and practice,ultimately accelerating the broader implementation of DCT.Additionally,increased support for training and communication is essential.关键词
去中心化临床试验/以患者为中心/定性访谈Key words
decentralized clinical trial/patient-focused/qualitative interviews分类
药学引用本文复制引用
张晓方,佟天琦,徐岩,孙婉,武阳丰..我国开展去中心化临床试验面临的主要风险和挑战及应对思考[J].中国食品药品监管,2025,(3):70-81,12.
