Application of Healthcare Failure Mode and Effect Analysis in the Management of Protocol Deviations in Clinical Trial
10.3870/j.issn.1004-0781.2024.10.019
- VernacularTitle: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
- Author:
Bo QIU
1
,
2
;
Haotian YANG
;
Runxuan DU
;
Haojing SONG
;
Xue SUN
;
Congyang DING
;
Wanjun BAI
;
Zhanjun DONG
Author Information
1. 河北省人民医院药学部,石家庄 050051
2. 河北省临床药学重点实验室,石家庄 050051
- Keywords:
Clinical trials;
Protocol deviations;
Healthcare failure mode and effects analysis
- From:
Herald of Medicine
2024;43(10):1645-1650
- CountryChina
- Language:Chinese
-
Abstract:
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.
