医疗失效模式与效应分析在临床试验方案偏离管理中的应用

Application of Healthcare Failure Mode and Effect Analysis in the Management of Protocol Deviations in Clinical Trial

目的规范临床试验的管理,降低方案偏离的发生率,为提高临床试验的质量提供参考。方法运用医疗失效模式与效应分析方法(HFMEA)确定目前方案偏离发生的潜在失效模式,量化并评估失效模式发生频率、严重程度及可探测度,计算风险优先数(RPN),提出相应的改进措施,统计分析HFMEA实施前后RPN值,评估改进效果。结果开展HFMEA活动后,14项潜在失效模式的RPN值明显下降(P<0.05);12项潜在失效模式的风险等级下降。HFMEA小组成员在发现问题和解决问题能力、沟通配合等方面得到了显著提高。结论HFMEA活动的实施有助于临床试验方案偏离的管理,可有效降低方案偏离的发生,为提高药物临床试验质量提供经验。

Objective To standardize the management of clinical trials in our hospital,reduce the incidence of protocol deviations,and provide a reference for improving the quality of clinical trials.Methods The healthcare failure mode and effect analysis(HFMEA)method was used to determine the potential failure modes of the current protocol deviation.The frequency,severity and detectability of failure modes were quantified and evaluated.The risk priority number(RPN)was calculated and the corresponding improvement measures were proposed.The RPN values before and after the implementation of HFMEA were statistically analyzed to evaluate the improvement effect.Results After the implementation of HFMEA activities,the RPN values of 14 potential failure modes decreased significantly(P<0.05);The risk level of 12 potential failure modes decreased.The HFMEA team members’ability in finding and solving problems,communication and cooperation were significantly improved.Conclusions The implementation of HFMEA activities contributes to the management of protocol deviation in clinical trials,can effectively reduce the occurrence of protocol deviation,and provides experience for improving the quality of drug clinical trials.