生命科学仪器2026，Vol.24Issue(2)：134-136,139,4.DOI:10.11967/2026240442
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
The Effect of Applying PDCA Cycle-Based Process Management in Phase Ⅰ Clinical Trial Ward Management
倪美意 1张剑1
作者信息
- 1. 复旦大学附属肿瘤医院,上海 200032
- 折叠
摘要
Abstract
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.关键词
Ⅰ期药物临床试验/病房管理/PDCA循环/质量控制Key words
Phase Ⅰ clinical trials/Ward management/PDCA cycle/Quality control分类
医药卫生引用本文复制引用
倪美意,张剑..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[J].生命科学仪器,2026,24(2):134-136,139,4.
