中国医学伦理学2024，Vol.37Issue(4)：399-407,9.DOI:10.12026/j.issn.1001-8565.2024.04.04
去中心化临床试验的挑战、对策及伦理审查要点
Challenges,countermeasures and key points of ethical review for decentralized clinical trials
摘要
Abstract
Decentralized clinical trials(DCT)are bringing new changes to clinical trials,the core concept of"patient-centered"must be adhered,and the safety and rights of research participants must be adequately safeguarded.Although DCTs have similarities with traditional clinical trials,they are not suitable for all clinical trials,and are more suitable for oral administration,stable condition of study participants,and longer duration of treatment in clinical trials.DCT,elements must be selected based on the characteristics of clinical trials,and strike a balance between improving the sense of gain,safety,and rights and dignity of research participants,as well as the quality of data collected.Currently,DCT in China face many challenges.To actively promote DCTs in China,regulatory regulations and guiding principles should be improved.Based on patient-centered design principles,the first discussion requires real-time online communication.Researchers should provide more clinical trial services,improve risk control and accessibility of medical assistance,use third-party convenient payments,ensure fair recruitment of research participants,consider compliance,validate digital health technology,remote monitoring and electronic informed consent compliance,ensure the security of data collection,transmission,and analysis,as well as strengthen multi-party training.Ethical review is one of the important means to protect the safety and rights of research participants.Ethics committees should focus on appropriate DCTs elements that are patient-centered,compliance and effectiveness of electronic informed consent,processing and reporting of security information,privacy protection of data collection,compliance of remote monitoring,family health follow-up,management of biological samples and experimental medical products,and training programs.The author believed that the complementarity and combination with traditional clinical trials will make DCTs elements implemented more easily and smoothly.By leveraging the power of scientific and technological advances,DCTs will boost the speed of China's drug and medical device research and development,enhance international competitiveness,and benefit more patients.关键词
去中心化临床试验/以患者为中心/伦理审查/数字健康技术Key words
decentralized clinical trial/patient-centered/ethical review/digital health technology分类
医药卫生引用本文复制引用
卜丽娟,江柯萱,周吉银..去中心化临床试验的挑战、对策及伦理审查要点[J].中国医学伦理学,2024,37(4):399-407,9.基金项目
2022年陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW02) （2022XRW02）
2020年度教育部人文社会科学研究青年项目"医患之间的心理授权及其对医患关系的影响研究"(20YJC840001) （20YJC840001）
