基于PDCA循环的过程管理应用于Ⅰ期药物临床试验病房管理中的效果OA
The Effect of Applying PDCA Cycle-Based Process Management in Phase Ⅰ Clinical Trial Ward Management
目的 探讨基于 PDCA[计划(Plan)、执行(Do)、检查(Check)、处理(Act)]循环的过程管理在Ⅰ期药物临床试验病房管理中的应用效果.方法 选取复旦大学附属肿瘤医院 2023 年 1-12 月期间实施常规病房管理的 157 例受试者为对照组,选取 2024 年 1-12 月期间实施基于 PDCA 循环的过程管理的 158 例受试者为观察组.比较两组临床试验方案依从性、不良事件发生情况及病房管理满意度.结果 两组不良事件总发生率及严重程度分级差异无显著性(P>0.05).与对照组相比,观察组临床试验方案依从性及病房管理满意度较高(P<0.05).结论 基于 PDCA 循环的过程管理应用于Ⅰ期药物临床试验病房管理的效果良好,可有效提升受试者依从性及满意度.
Objective:To explore the application effect of process management based on PDCA[Plan,Do,Check and Act)]cycle in ward management of phase I drug clinical trial.Methods:157 patients with routine ward management in the Cancer Hospital affiliated to Fudan University from January to December,2023 were selected as the control group,and 158 pa-tients with PDCA cycle-based process management from January to December,2024 were selected as the observation group.The compliance of clinical trial scheme,the occurrence of adverse events and the satisfaction of ward management were compared between the two groups.Results:There was no significant difference in the total incidence and severity of adverse events between the two groups(P>0.05).Compared with the control group,the compliance of clinical trial scheme and the satisfaction of ward management in the observation group were higher(P<0.05).Conclusion:The process management based on PDCA cycle is effective in ward management of phase I drug clinical trial,which can effectively im-prove the compliance and satisfaction of subjects.
倪美意;张剑
复旦大学附属肿瘤医院,上海 200032复旦大学附属肿瘤医院,上海 200032
医药卫生
Ⅰ期药物临床试验病房管理PDCA循环质量控制
Phase Ⅰ clinical trialsWard managementPDCA cycleQuality control
《生命科学仪器》 2026 (2)
134-136,139,4
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