突发公共卫生事件中临床试验受试者权益保护探讨

Protection of the Rights and Interests of Clinical Trial Subjects in Sudden Public Health Emergencies

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.