关键词: Ⅱa临床试验, 质量风险管理, 失效模式, 影响与危害性分析

Abstract: Objective To establish a general method for quality risk management of phaseⅡa clinical trials of innovative anti-tumor drugs.Methods Based on theories of quality risk management, literature research and questionnaire survey, failure mode, effects and criticality analysis (FMECA) was used to construct the failure mode of phase Ⅱa clinical trials of innovative anti-tumor drugs. By means of hazard analysis, the risk priority number (RPN) of each failure mode was obtained.Results There were 25 non-critically acceptable low risks such as“lack of relevant documents and records for drug recovery”with RPN <15, and 18 medium risk failure modes such as“without timely treatment of combined medication”with 15≤RPN <25. There were 31 high-risk failure modes with RPN≥25, such as “the problem was not found and resolved in a timely manner through the inspection of the auditor”.Conclusion By analyzing the RPN value, more important risks in the “subject management”“data management”“safety monitoring”and“quality assurance”links with higher risks in clinical trials are identified, and risk control recommendations are proposed.

Key words: phaseⅡa clinical trial, quality risk management, failure mode, effects and criticality analysis