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

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

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。

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.