摘要
目的 针对临床试验过程中出现的妊娠事件进行分析,增加对受试者权益和安全的保护。方法 分析本院临床试验机构发生的2例妊娠事件,结合文献和实际工作经验,提出对策和建议。结果 通过改善试验方案设计、给受试者购买保险、加强受试者知情和宣教、加强伦理启动前审查及跟踪审查,降低妊娠相关风险、保护受试者的权益和安全。结论 通过增加对临床试验过程中妊娠事件的预防和管理措施,减少妊娠事件对试验各方带来的风险,增加对受试者权益和安全保护。
Objective To analyze the pregnancy events in the process of clinical trials, and to increase the protection of the rights and safety of subjects. Methods Two cases of pregnancy events occurred in the clinical trial institution of our hospital were analyzed, combined with literature and practical work experience, countermeasures and suggestions were put forward. Results Pregnancy-related risks can be reduced and the rights and safety of the subjects can be protected by improving the design of the trial protocol, purchasing insurance for the subjects, strengthening the awareness and education of the subjects, strengthening the ethical review before initiation and follow-up review. Conclusion By increasing the prevention and management measures of pregnancy events in the process of clinical trials, the risks of pregnancy events to all parties in the trial could be reduced, and the protection of the rights and safety of the subjects could be increased.
作者
顾海鹰
沈敏敏
蒋凤琴
王沛
GU Hai-ying;SHEN Min-min;JIANG Feng-qin;WANG Pei(The Fifth Clinical Medical College of Zhejiang Chinese Medical University;Huzhou Central Hospital)
出处
《医院管理论坛》
2024年第1期68-70,共3页
Hospital Management Forum
关键词
临床试验
妊娠事件
应对策略
Clinical trials
Pregnancy events
Countermeasures
