预防用疫苗临床试验安全性分析和报告的考虑

The consideration about safety data analysis and expression in instructions of vaccine clinic trials

预防用疫苗(疫苗)的安全性是临床试验重点关注和评价的内容之一。本文结合近年来疫苗注册试验的审评实践,汇总了安全性分析和报告中的常见问题并相应提出系列思考和建议,包括探讨了安全性分析中统计学的作用,提出了安全性分析和报告的框架,涉及分析内容、分析指标和分析维度,其中关注了严重程度的分析;强调安全性风险信号应主动分析,鼓励基于循证的要求开展安全性评价;同时就说明书中收载安全性研究信息的基本原则、以及各期试验及不同受试者安全性数据综合考虑的问题进行了探讨,供疫苗注册申请人参考和借鉴,以促进我国疫苗临床研发和评价。

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation.Based on the review practice of vaccine registration clinical trials in recent years,we summarized the common problems in safety analysis and report and accordingly puts forward a series of thoughts and suggestions,including discussing the role of statistics in safety analysis,putting forward the framework of safety analysis and report involved analysis content,analysis index and analysis dimension,in which attention is paid to the severity analysis;emphasizing the initiative analysis on risk signal and encouraging the evidence based initiative safety evaluation.At the same time,this paper discusses the basic principles of the presentation of safety data in the package inserts,as well as the comprehensive consideration of the safety data of each phase of the trial and different subjects.It can be used for reference by sponsor to promote vaccine clinical research and evaluation in China.