药物临床试验中不良事件管理问题分析

Problems with Reports of Adverse Events in Drug Clinical Trials

目的分析药物临床试验中不良事件管理问题,提高临床试验的质量和水平。方法收集某医院临床试验机构21项临床试验项目质控报告,依据《药物临床试验数据现场核查要点》,对其中有关不良事件管理方面存在的问题进行统计分析。结果21个项目中发现不良事件管理相关问题197次,其中收集起点与试验方案是否一致方面的问题17次(占8.6%);未跟踪随访到终点方面26次(占13.2%);不良事件名称记录不规范方面58次(占29.4%);不良事件漏记方面49次(占24.9%);异常有无临床意义判定不合理方面34次(占17.3%);与试验药物相关性判定不合理方面13次(占6.6%)。结论不良事件的记录与评价方面存在问题较多,需临床试验机构及研究者在临床试验开展过程中重点关注。

Objective To analyze the problems with reports of adverse events in clinical trials and improve the quality and level of clinical trials.Methods The quality control reports of 21 clinical trials in an institution were collected,and the problems with wording of adverse events were statistically analyzed according to“Key Points for On-site Verification of Drug Clinical Trial Data”.Results In the 21 clinical trials,197 errors related to reports of adverse events were found,Among them,17 errors involved the consistency between the starting-time of collection and the trial protocol(8.6%),26 were related to incomplete follow-up(13.2%),58 were concerned with substandard recording of names of adverse events(29.4%),49 were the lack of reports of adverse events(24.9%),34 were cases of misjudgment of clinical significance of abnormalities(17.3%),and 13 were cases of misjudgment of correlations with the tested drugs(6.6%).Conclusion There are a number of problems with the recording and evaluation of adverse events,which deserves the attention from clinical trial institutions and researchers in the course of clinical trials.