以前瞻性队列研究为评价方式的新药Ⅳ期临床试验质量风险管理研究

On Quality Risk Management in Phase Ⅳ of New Drug Clinical Trial Evaluated by Prospective Cohort Study

目的:本研究力图从申办方的角度,对以前瞻性队列研究为评价方法的新药Ⅳ期临床试验质量风险管理进行探讨。方法:通过文献研究法与专家问卷咨询法,以及失效模式与影响分析(Failure Modes and Effect Analysis,FMEA)与风险优先数法(Risk Priority Number,RPN)进行风险评估。结果与结论:构建了以前瞻性队列研究为评价方法的Ⅳ期临床试验的FMEA,并得到各失效模式与失效原因的RPN值。根据RPN值结果综合分析,识别试验中风险相对集中的结构与环节,针对相对重要的风险事故与风险因素,给出风险控制建议。

Objective： To discuss the quality risk management in phase Ⅳ of new drug clinical trial using the prospective cohort study as evaluation method from the perspective of sponsor. Methods： The risk assessment was carried out by using the following methods, such as literature research, expert questionnaire, the Failure Modes and Effect Analysis（FMEA） as well as the Risk Priority Number（RPN）. Results and Conclusion： First of all, FMEA about phase Ⅳ of new drug clinical trial was established by using the prospective cohort study as evaluation method. The RPNs of each failure mode and failure reason were obtained. Secondly, the relatively concentrated risk in the trial was identified according to the comprehensive analysis of the RPNs. Finally, the suggestions for risk control were put forward according to the relatively important risk accidents and risk factors.