PDCA循环在渐冻症（ALS）临床试验启动的应用实践
陈春华^1，2，张高小²，于沛²，单璐琛^2*

1.中山大学附属第一医院， 药学部，广东 广州 510030

2.暨南大学药学院， 广东 广州 510632

摘要：目的：在新药TBN治疗渐冻症（ALS）II 期临床试验项目启动工作中引入PDCA循环法，实现项目质量管理持续改进的目标。方法：以3家研究中心两个季度数据，评价PDCA循环方法干预前后研究中心启动过程的试验执行与质量变化情况。结果：干预后的项目启动标准操作流程与文件管理体系进一步优化，人员培训模式更多元化。增加对研究相关人员的培训次数，试验文件归档错误率降低；受试者安全性事件报告更及时，受试者访视项目漏报或少报的情况有所减少。结论：PDCA循环方法的干预提升了项目质量水平，通过加强ALS项目整体的管理能力，使ALS试验数据及受试者安全等管理工作的质量得到有效保障。

关键词：PDCA循环法；临床试验启动；质量管理

The application practice of PDCA cycle in the initiation of clinical trials for ALS

CHEN Chunhua^{1, 2}, ZHANG Gaoxiao², YU Pei², SHAN Luchen^2*,

1.Department of Pharmacy, The First Aff'il iated Hospital of Sun Yat-sen University, Guangzhou 510030, Guangdong, China；

2. College of Pharmacy, Jinan University, Guangzhou 510632, Guangdong, China)

Abstract：bjective: Introducing the PDCA cycle method in the initiation of the Phase II clinical trial of the new drug TBN for the treatment of ALS to achieve the goal of continuous improvement in project quality management. Methods: Data from three sites over two quarters were used to evaluate the changes in the trial execution and quality of the site initiation process before and after the intervention of the PDCA cycle method. Results: After the intervention, the project initiation standard operating procedures and the document management system were further optimized, and the personnel training model became more diversified. Increased the number of training sessions for site personnel , the error rate of trial document filing was reduced; the reporting of subject safety events became more timely, and the situation of under-reporting or missing reporting of subject visit items was reduced. Conclusions: The intervention of PDCA cycle method has improved the quality level of the project. By strengthening the management ability of ALS project team, the quality of trail data and subject safety management work has been effectively guaranteed.

Keywords：PDCA cycle method; Clinical trial initiation; Quality management

参考文献；

[1]樊东升, 陈璐. 运动神经元病的诊断和分类[J]. 中华神经科杂志, 2019, (12): 1065-1066-1067. 

[2]2 李沙, 王磊, 陈海南, et al. 川芎嗪硝酮衍生物 在大鼠体内的组织分布研究[J]. 中国临床药理学杂 志, 2011, 27(01): 42-45. 

[3]王金霞. 临床试验项目准备及启动阶段的时间管 理[J]. 上海医药, 2019, 40(15): 72-74. 

[4]杨敏, 程国华. 药物临床试验各环节的质量管理 [J]. 中国现代应用药学, 2019, 36(15): 1967-1971. 

[5]叶林淼. 六西格玛管理用于药物临床试验启动前 流程优化的初步探讨[J]. 临床合理用药杂志, 2021, 14(14): 175-176. 

[6]蔡君龙, 吴建元, 陈博, et al. 医疗机构对临床 试验项目立项审查工作的改进方法[J]. 中国医药导 报, 2019, 16(18): 159-162. 

[7]Lai J, Forney L, Brinton D L, et al. Drivers of start-up delays in global randomized clinical trials[J]. Ther Innov Regul Sci, 2021, 55(1): 212-227. 

[8]孔敏, 季晓慧, 朱露莎, et al. Pdca 循环法在改 进药物临床试验质量管理中的应用[J]. 中华医学科 研管理杂志, 2021, 34(01): 27-30.

[9]鲁萌, 朱静静, 朱晓芳, et al. 品管圈在持续改 进药物临床试验质量中的应用[J]. 中国现代应用药 学, 2020, 37(02): 237-241.

[10]仲丽, 殷佩浩, 杨帆平, et al. Pdca 循环法在我 院药物临床试验资料管理工作中的实践[J]. 中国中 医药现代远程教育, 2017, 15(01): 39-41. [11]全婷, 曾代文, 严晓梁. 药物临床试验机构质量 管理[C]. 中国药理学会药物临床试验专业委员会首 届学术研讨会, 中国上海, 2013. 

[12]高杨勇. X 公司药物临床试验质量管理优化研究 [D].吉林大学, 2020.