药物Ⅰ期临床试验实施阶段质量风险管理研究

Study on Quality Risk Management in the Implementation of Phase Ⅰ Clinical Trials

目的:建立药物Ⅰ期临床试验实施阶段质量风险管理的一般方法方法:以质量风险管理理论为指导,运用失效模式、影响与危害性分析法(FMECA),结合文献研究和调查问卷法,对药物Ⅰ期临床试验实施阶段进行风险评估。结果与结论:药物Ⅰ期临床试验实施阶段共有"研究场地管理""SOP管理""受试者管理""试验用药物管理""生物样本管理""试验记录管理""安全性报告管理""质量保证"8个环节下87个失效模式和274个失效原因会影响到研究质量其中"SOP的制定不符合当时当地药品相关法律法规的要求""招募质量低"及"受试者用药剂量、时间、方式及饮水量错误"等14个失效模式属于高风险,应实施风险控制;从"受试者管理""SOP管理""试验数据记录管理""试验用药物管理"及"研究场地管理"五个方面提出了风险控制措施和建议。

Objective:To establish a general method for quality risk management in the implementation of Phase I clinical trials.Methods:The theory of quality risk management was used as a guidance.The failure mode effect and criticality analysis(FMECA)were combined with the method of literature research and questionnaires to conduct the risk assessment of Phase I clinical trial of drugs.Results and Conclusion:On the stage of implementation of drug Phase I clinical trials,there were 87 failure modes and 274 failure causes affecting the quality of research through the following 8 links:management of the research sites,SOP management,management of subjects,management of testing drugs,management of biological samples,management of testing records,management of safety report and quality assurance.Among them,14 failure modes were at high risks.For example,the formulation of SOP did not meet the requirements of local drug-related laws and regulations at the time,the recruitment quality was low,and the dosage,the medication time and mode and the amount of drinking water for the subjects were wrong,so the risk control should be implemented.Risk control measures and recommendations were proposed from the following aspects:management of subjects,SOP management,management of testing records,management of testing drugs and management of the research sites.