基于多学科全流程管理的抗肿瘤药物Ⅰ期临床试验受试者管理模式探讨<sup>★</sup>

doi:10.3969/j.issn.2095-1264.2024.02.13

首页 > 过刊浏览>2024年第2期 >222-228. DOI:10.3969/j.issn.2095-1264.2024.02.13

基于多学科全流程管理的抗肿瘤药物Ⅰ期临床试验受试者管理模式探讨★
DOI:
                        10.3969/j.issn.2095-1264.2024.02.13
                    
作者:
                        
                        
                    
作者单位:1.湖南中医药大学护理学院，湖南 长沙，410208;2.湖南省肿瘤医院 早期临床研究中心，湖南 长沙，410013;3.湖南省肿瘤医院 护理部，湖南 长沙，410013
作者简介:赵姣，女，硕士研究生，主管护师，研究方向：肿瘤护理。
通讯作者:李金花，硕士，主任护师，硕士生导师，研究方向：肿瘤症状管理、肿瘤护理教育。
中图分类号:R-052;R969;R979.1
基金项目:湖南省卫生健康高层次人才支持计划资助（20240219-1004）；湖南省创新型省份建设专项科普专题项目（2022ZK4156）。

Exploration of subjects management model in phase I clinical trial of anti-cancer drugs based on multidisciplinary whole process management^★

Author:

Affiliation:

1.School of Nursing, Hunan University of Chinese Medicine, Changsha, 410208, China;2.Early Clinical Trial Center, Hunan Cancer Hospital, Changsha, 410013, China;3.Nursing Department, Hunan Cancer Hospital, Changsha, 410013, China

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摘要:

目的基于多学科合作的全流程管理，探讨抗肿瘤药物I期临床试验受试者管理模式并分析应用效果，为抗肿瘤药物I期临床试验受试者的规范管理提供参考依据。方法建立多学科合作的全流程管理模式，对接受抗肿瘤药物I期临床试验的受试者提供从入院前至出院后的全流程管理。结果实行多学科合作的全流程管理后，受试者临床试验方案违背发生率从10.3%降低到2.1%，受试者护理不良事件发生率从8.5%降低到1.1%，患者家属满意度得到提高。结论实施多学科全流程管理模式可有效降低抗肿瘤药物I期临床试验方案违背率，并提高肿瘤受试者满意度和随访依从性，值得临床推广应用。

Abstract:

Objective To explore the management model of subjects in phase I clinical trial of anti-cancer drugs from a multidisciplinary whole process management perspective, and analyze its application effects, in order to provide a reference for the standardized management of subjects in phase I clinical trials of anti-cancer drugs.Methods A multidisciplinary full-process management model was established to provide comprehensive management for subjects in phase I anti-cancer drug clinical trials, from pre-admission to post-discharge.Results Following the implementation of the multidisciplinary management approach, the rate of clinical trial protocol violations decreased from 10.3% to 2.1%, and the incidence of adverse nursing care events dropped from 8.5% to 1.1%. The satisfaction levels among patients' family members were also improved.Conclusion The implementation of a multidisciplinary whole process management model can effectively reduce the rate of protocol violation in phase I clinical trials of anti-cancer drugs, and improve the satisfaction and follow-up compliance of tumor subjects, which is worthy of clinical application and promotion.