摘要
目的为突发公共卫生事件中临床试验受试者的权益保护提供参考。方法分析突发公共卫生事件中我国受试者权益保护的现状,从伦理审查、受试者管理、试验药物发放、严重不良事件上报及处理、远程监查五方面分析受试者权益保护存在的问题,并提出针对性的建议。结果与结论突发公共卫生事件对临床试验项目的实施有一定影响,建议完善我国突发公共事件中临床试验运行和管理的制度与标准操作规程,采用智能化信息技术实施远程项目受理、访视、监查、伦理审查,以促进临床试验的智能化、数字化、远程化,提升突发公共卫生事件中受试者的权益保护水平。
Objective To provide a reference for the protection of the rights and interests of clinical trial subjects in sudden public health emergencies.Methods The current situation of the protection of the rights and interests of clinical trial subjects in public health emergencies in China was analyzed.The problems such as ethical review,clinical trial subject management,clinical trial drug distribution,reporting and handling of serious adverse events,and remote monitoring in the protection of the rights and interests of clinical trial subjects were analyzed to put forward targeted suggestions.Results and Conclusion Public health emergencies have a certain impact on the implementation of clinical trial projects.It is recommended to improve the system and standard operating procedures for the operation and management of clinical trials in sudden public health emergencies in China,and adopt intelligent information technology to implement remote project acceptance,visits,monitoring,and ethical review,in order to promote the intelligence,digitization and remoteness of clinical trials,and improve the protection level of the rights and interests of trial subjects in sudden public health emergencies.
作者
程毅
李丽华
布格拉·米吉提
张翌韦
申洁
刘春丽
杨建华
CHENG Yi;LI Lihua;Bugela MIJITI;ZHANG Yiwei;SHEN Jie;LIU Chunli;YANG Jianhua(The First Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China 830011;Maternal and Child Care Service Center of Urumqi,Urumqi,Xinjiang,China 830011)
出处
《中国药业》
CAS
2023年第13期6-9,共4页
China Pharmaceuticals
基金
国家科技重大新药创制专项项目[2020ZX09201030]。
关键词
突发公共卫生事件
临床试验
受试者
权益保护
sudden public health emergency
clinical trials
trial subjects
protection of the rights and interests
