临床试验过程中妊娠事件分析及应对策略
Analysis of Pregnancy Events during Clinical Trials and Countermeasures
顾海鹰 1沈敏敏 1蒋凤琴 1王沛1
作者信息
- 1. 浙江中医药大学第五临床医学院/湖州市中心医院
- 折叠
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.
Abstract
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.
关键词
临床试验/妊娠事件/应对策略Key words
Clinical trials/Pregnancy events/Countermeasures引用本文复制引用
出版年
2024
NETL
NSTL
维普
万方数据