摘要
目的:分析某三甲医院药物临床试验严重不良事件(SAE)报告分布及报告过程中出现的主要问题,探讨提高SAE报告质量的有效措施,为完善临床试验机构SAE管理体系及质量管理体系提供参考依据。方法:查阅该医院2017~2021年报告的药物临床试验SAE报告,分析报告科室、受试者性别、与试验药物的相关性,以及报告过程中出现的主要问题。结果:共报告SAE 193例(报告366例次),血液科、神经外科、心血管内科、内分泌科、重症医学科报告数量较多。性别方面,男性受试者(156例,80.83%)多余女性(37例,19.17%)。SAE类型方面,导致住院最多(99例,51.30%),其次为延长住院时间、危及生命、死亡、其他重要医学事件。与试验药物关系方面,“可能无关”占比最大(100例,51.81%)。SAE报告过程中存在SAE报告时间超过时限(迟报),报告内容填写不规范,原始记录支撑资料不完整,报告人资质不合理,递交信填写不规范等问题。结论:严格遵守临床试验法律法规及相关指导文件要求,加强研究者培训,完善相关管理制度和SAE报告指导文件,增强伦理审查力度,加强对受试者的宣教,加强临床试验过程中申办方、研究者以及机构三方沟通,均有利于提高SAE报告的及时性和规范性,以保障受试者安全和权益。
Objective: To analyze the distribution and main problems of serious adverse event (SAE) reports of drug clinical trials in a comprehensive tertiary first-class hospital, and explore effective measures to improve the quality of SAE reports. To provide reference for improving the SAE management sys-tem of drug clinical trial institutions. Method: We reviewed the SAE reports of drug clinical trials reported from 2017 to 2021, and analyzed the reporting department, gender of subjects, correla-tion with clinicaltrial drugs, and main defects in the reports. Results: A total of SAE reports for 193 subjects (366 times) were reported. There were many reports from hematology department, neu-rosurgery department, cardiovascular medicine department, endocrinology department and critical care medicine department. In terms of gender, male subjects (156, 80.83%) were more than female subjects (37, 19.17%). In terms of SAE types, the reports leading to hospitalization were the most (99, 51.30%), followed by prolonged hospitalization, life-threatening, death, and other im-portant medical events. In terms of the correlation with clinical trial drugs, “probably unrelated” accounted for the largest proportion (100, 51.81%). During the SAE reporting process, there were problems such as the SAE reporting time exceeded the time limit (delayed reporting), the report content was not filled in accurately, the supporting data of the original record was incomplete, the reporter’s qualification was unreasonable, and the submission letter was filled in incorrectly. Con-clusion: Strictly complying with the requirements of clinical trial laws and regulations and relevant guidance documents, strengthening the training of investigators, improving the relevant management system and SAE report guidance documents, enhancing the strength of ethical reviews, strengthening the publicity and education of subjects, and strengthening communication among sponsors, investigators and institutions in the process of clinical trials, are conducive to improving the timeliness and standardization of SAE reports, and protecting the safety and rights of subjects.
出处
《药物资讯》
2023年第5期470-476,共7页
Pharmacy Information
