Application of healthcare failure mode and effects analysis in risk management of drug clinical trial projects
10.3760/cma.j.cn111325-20240820-00682
- VernacularTitle:医疗失效模式与效应分析在药物临床试验项目风险管理中的应用
- Author:
Qingqing WANG
1
;
Miao MIAO
1
;
Fei LIU
1
;
Haijuan ZHAO
1
;
Lang ZHAO
1
;
Yao LIU
1
;
Han YANG
1
;
Shuang ZHAO
1
;
Xin WANG
1
Author Information
1. 北京医院临床试验研究中心/国家老年医学中心/中国医学科学院老年医学研究院，北京 100730
- Publication Type:Journal Article
- Keywords:
Healthcare failure mode and effect analysis;
Drug clinical trial institutions;
Risk management;
Delphi method
- From:
Chinese Journal of Hospital Administration
2025;41(6):485-490
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To improve the risk management process for clinical trial projects using healthcare failure mode and effect analysis(HFMEA), for references for enhancing the risk identification and preventing capabilities of drug clinical trial institutions.Methods:From June to December 2022, this study focused on the project management process of a clinical trial centre in a tertiary public hospital. Following HFMEA procedures, a research team was established. Core processes prone to failure modes in the drug clinical trial project management and their potential failure modes were identified through group discussions, literature analysis, the Delphi method, and decision tree analysis. High-risk failure modes were screened via risk assessment, corresponding improvement measures were formulated and performed, and their effectiveness was validated.Results:The study identified 6 main processes, 17 sub-processes, and 102 potential failure modes. Delphi analysis confirmed 88 failure modes, with 19 having a failure risk priority number(RPN)≥8.00. Decision tree analysis identified 16 high-risk failure modes, involving 5 main processes and 10 sub-processes. Targeted improvements, such as adopting standardized hospital contract templates and setting deadlines for final payment settlement, etc., were implemented. One year post-implementation(January 2024), the RPN for all 16 high-risk failure modes were<8.00.Conclusions:HFMEA could help hospital clinical trial institutions comprehensively and systematically identify high-risk failure modes in the project management process, develop targeted improvement measures, and improve the level of drug clinical trial project management.
