肿瘤受试者对以患者为中心的药物临床试验的参与意愿及其影响因素调查  

A survey of cancer subjects’willingness to participate in patient-centric clinical trials and their influencing factors

作　　者：吴清 孙超 吴大维 汤骐羽 贾硕鹏 唐玉 黄慧瑶 房虹 于锋 李宁 WU Qing;SUN Chao;WU Dawei;TANG Qiyu;JIA Shuopeng;TANG Yu;HUANG Huiyao;FANG Hong;YU Feng;LI Ning(Department of Clinical Trial Center,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100021,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing,210009,Jiangsu,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京100021 [2]中国药科大学基础医学与临床药学学院,江苏南京210009

出　　处：《肿瘤药学》2024年第6期653-661,共9页Anti-Tumor Pharmacy

基　　金：首都卫生发展科研专项项目(首发2022-2Z-40211);Pfizer Independent Medical Education(ID#76431397)。

摘　　要：目的 调研肿瘤受试者对以患者为中心的药物临床试验的认知度、参与意愿及其影响因素,探讨如何促进以患者为中心的药物临床试验的落地。方法 采用便利抽样法,对2023年3月至8月在中国医学科学院肿瘤医院参与抗肿瘤药物临床试验的肿瘤患者进行问卷调研。结果 有效问卷403份(95.7%),肿瘤受试者对以患者为中心的药物临床试验的认知度为24.3%,但整体参与意愿较高(70.0%),尤其是远程寄送药(88.6%)和远程访视(86.6%)。单因素分析结果显示,患者所在地区、有无宗教信仰、肿瘤确诊时长和因参与临床试验来往机构次数与参与意愿有关(P<0.05)。多元logistic回归分析结果表明,肿瘤确诊时长>5年、因参与临床试验来往机构次数≥4次的患者参与意愿较高。结论 肿瘤受试者对以患者为中心的药物临床试验参与意愿高,利用远程技术可减轻患者负担,充分考虑患者所关心的安全性、隐私性及充分知情权等对其成功实施有积极意义。Objective To investigate the cancer subjects'awareness of patient-centric clinical trials,their willingness to participate and their influencing factors,in order to explore how to promote patient-centric clinical trials come to fruition from the patients'perspective.Methods Convenience sampling method was used to conduct a questionnaire survey on can‐cer subjects who participated in clinical trials between March and August 2023 at the Cancer Hospital of the Chinese Acad‐emy of Medical Sciences.Results There were 403(95.7%)valid questionnaires.Only 24.3%cancer subjects had some awareness of patient-centric clinical trials.But there was a high overall willingness(70.0%)to participate in patient-cen‐tric clinical trials,especially in the sessions of remote delivery of medication(88.6%)and remote visits(86.6%).The results of univariate analysis showed that the location of patients,presence of religion,length of tumor diagnosis,and number of vis‐its to the institution for clinical trial participation were significantly associated with their willingness to participate in pa‐tient-centered clinical trials (P<0.05). The results of multivariate logistic regression analysis showed a high willingness to participate among patients with a tumor diagnosis >5 years and ≥4 visits to the institution for clinical trial participation.Conclusion Cancer patients have a high willingness to participate in patient-centric clinical trials. Using remote technolo‐gy to reduce the burden on patients, and fully considering the concerns of patients about safety, privacy and full right to know, have a positive significance for the implementation of patient-centric clinical trials.

关 键 词：肿瘤受试者 以患者为中心的药物临床试验 参与意愿 影响因素 调研问卷 

分 类 号：R979.1[医药卫生—药品] R-052[医药卫生—药学]