基于伦理审查的视角对临床试验中非预期严重不良事件的分析

Ethical analysis of unanticipated serious adverse events in clinical trials based on the perspective of ethical review

目的分析2016年1月至2017年12月我院伦理委员会非预期严重不良事件的分布和特点。方法根据299例非预期严重不良事件报告,从科室分布、注册分类、临床试验分期、非预期严重不良事件情况关系判定等方面做回顾性分析。结果在伦理委员会收到的严重不良事件报告中,非预期事件较多,其中心内科(188例,62. 8%),第三类医疗器械临床试验(138例,46. 15%),Ⅲ期药物临床试验(119例,39. 80%),导致住院(258例,86. 29%),肯定无关(164例,54. 85%)中较多。结论伦理委员会应厘清非预期概念,并对非预期事件进行充分和全面的评估。

Objective To analyze the distribution and characteristics of unanticipated serious adverse events in our ethics committee from January2016 to December 2017.Methods According to the 299 unanticipated serious adverse events report of the ethics committee of our hospital,a retrospective analysis was made from the aspects of departmental distribution,registration classification,clinical trial phase,and relationship judgment with test product.Results In the report of serious adverse events received by the ethics committee,there were more unanticipated events,cardiology(188 cases,62.8%),and third class medical device clinical trials(138 cases,46.15%),phaseⅢdrug clinical trials(119 cases,39.80%),the highest hospitalization(258 cases,86.29%),certainly not related to the highest(164 cases,86.29%).Conclusion The ethics committee should clarify the unanticipated concept and conduct a full and comprehensive assessment of unanticipated events.