全过程质量控制在Ⅰ期临床试验管理中的应用  

Application of whole-process quality control in phase Ⅰ clinical trial management

作　　者：刘英 漆璐 佟媛旭 魏雅丽 刘晨 刘慧娟 张薇 王兴河 LIU Ying;QI Lu;TONG Yuan-xu;WEI Ya-li;LIU Chen;LIU Hui-juan;ZHANG Wei;WANG Xing-he(Phase Ⅰ Clinical Trail Centre,Bejing Shijitan Hospial,Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室,北京100038

出　　处：《中国新药杂志》2021年第3期254-258,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09304026);首都医科大学附属北京世纪坛医院院基金资助项目(2019-q24)。

摘　　要：目的:探讨全过程质量控制在Ⅰ期临床试验管理中的应用效果。方选:选择实施全过程质量控制前(2018年1月—2019年1月)和实施后(2019年6月—2020年6月)的96例受试者和40名研究护士作为研究对象,分别作为对照组和研究组,实施传统的回顾式方法及全过程质量控制质量管理流程,采用量表分析法比较两组受试者依从性、脱落率及满意度,并评价研究护士Ⅰ期试验管理知识情况。结果:研究组依从性显著高于对照组(t=11.41,P <0.001),脱落率低于对照组(χ^(2)=3.215,P=0.036),满意度显著高于对照组(t=8.984,P <0.001)。研究组护理人员管理规范、护理相关标准操作规程、急救技能知识、实操技能、病历书写、质量控制相关知识优于对照组。结论:在Ⅰ期临床试验质量管理中实施全过程质量控制,可提高Ⅰ期临床试验的质量,更好地保护受试者权益。Objective: To explore the application effect of whole process quality control in phase Ⅰ clinical trial management. Methods: A total of 96 subjects and 40 research nurses were included in the clinical trial. The group before the implementation of whole-process management (2018-01—2019-01) was regarded as the control group,and the traditional phase Ⅰ clinical trial management process was implemented. The group before the implementation of the whole process management (2019-06—2020-06) was regarded as the research group,and the implementation of the whole process quality control. Scale analysis was used to compare the compliance,shedding rate and satisfaction of the two groups of subjects. The management knowledge was evaluated. Results: The compliance of the study group was significantly higher than that of the control group (t = 11. 41,P < 0. 001). The drop off rate of the study group was significantly lower than that of the control group (χ^(2)= 3. 215,P = 0. 036),and the satisfaction of the study group was significantly higher than that of the control group (t = 8. 984,P < 0. 001). The nursing staff management standard,nursing related standard operating procedures,first aid skills,practical skills,medical record writing,quality control related knowledge of the study group were better than those of the control group.Conclusion: The implementation of whole process quality control in phase Ⅰ clinical trial quality management can improve the quality of phase Ⅰ clinical trial,improve the quality of nursing,and protect the rights and interests of subjects.

关 键 词：全过程管理 Ⅰ期临床试验 质量控制 

分 类 号：R969.4[医药卫生—药理学]