2020年版GCP实施后可疑且非预期严重不良反应报告分析

Analysis of Suspected Unexpected Serious Adverse Reaction Reports After the Implemention of the Good Clinical Practice(2020 Edition)

目的促进可疑且非预期严重不良反应(SUSAR)报告的管理。方法收集2020年7月至10月由申办者报告至药物临床试验机构办公室的SUSAR报告1323份,回顾性分析其报告中试验项目分期、试验用药物的注册分类、转归情况、事件性质(类别)等。结果试验项目分期中,发生于Ⅱ期药物临床试验项目245份(18.52%),Ⅲ期药物临床试验项目1078份(81.48%)。注册分类中,化学药品1类54份(4.08%)、5类9份(0.68%),生物制品1类1212份(91.61%)、2类43份(3.25%)、7类2份(0.15%)、9类3份(0.23%)。SUSAR转归情况中,结局为痊愈465份(35.15%),好转/缓解220份(16.63%),未好转/未缓解/持续454份(34.32%),致死153份(11.56%)。结局为未好转/未缓解/持续与致死的SUSAR试验用药物中,化学药品1类35份(64.81%),生物制品1类551份(45.46%)、2类18份(41.86%);结局为致死的SUSAR试验用药物中,生物制品1类148份(12.21%)、2类4份(9.30%),化学药品5类1份(11.11%)。SUSAR事件性质(类别)分布中,致死或危及生命的SUSAR 272份(20.56%),非致死或危及生命的SUSAR 1051份(79.44%)。结论药物临床试验机构需对生物制品1类与化学药品1类临床试验中的SUSAR进行重点审核,并加强此类试验中的风险预警,以便早期识别。

Objective To promote the management of suspected unexpected serious adverse reaction(SUSAR)reports.Methods A total of 1323 SUSAR reports submitted to the clinical trial institution office by sponsors from July to October 2020 were collected,and the staging of drug clinical trials,registration classification of trial drugs,outcome and nature(category)of the event in the reports were analyzed retrospectively.Results Among the staging of durg clinical trials,245(18.52%)reports occurred in phaseⅡof drug clinical trials,1078(81.48%)reports occurred in phaseⅢof drug clinical trails.Among the registration classification of trial drugs,there were 54(4.08%)reports of classification 1 chemical drugs,9(0.68%)reports of classification 5 chemical drugs,1212(91.61%)reports of classification 1 biological products,43(3.25%)reports of classification 2 biological products and 2(0.15%)reports of classification 7 biological products,3(0.23%)reports of classification 9 biological products.Among the outcome reports of SUSAR,there were 465(35.15%)reports of recovery,220(16.63%)reports of improvement/remission,454(34.32%)reports of non-improvement/non-remission/continuation,and 153(11.56%)reports of death.Among the SUSAR reports with non-improvement/non-remission/continuation and fatal outcomes,there were 35(64.81%)reports of classification 1 chemical drugs,551(45.46%)reports of classification 1 biological products and 18(41.86%)reports of classification 2 biological products.Among the SUSAR reports with fatal outcomes,148(12.21%)reports of classification 1 biological products,4(9.30%)reports of classification 2 biological products,and 1(11.11%)report of classification 5 chemical drugs.In the nature(category)distribution of SUSAR events,272(20.56%)reports of fatal or life-threatening SUSAR,and 1051(79.44%)reports of non fatal or life-threatening SUSAR.Conclusion Clinical trail institutions should focus on reviewing the SUSAR in the clinical trials of classification 1 biological products and classification 1 chemical drugs,and strengthen the risk early warning in such trials for early identification.