公众对远程临床试验的接受度及其影响因素的调查分析  

Survey and analysis on public acceptance and its influencing factors towards remote clinical trials

作　　者：左泽锦[1] 胡敏 陈蕾[1] 黄鹏 张庆 范海燕 吴维娟 ZUO Ze-jin;HU Min;CHEN Lei;HUANG Peng;ZHANG Qing;FAN Hai-yan;WU Wei-juan(Department of Clinical Research Management,West China Hospital,Sichuan University,Chengdu SICHUAN 610041,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing JIANGSU 210009,China;IQVIA,SHANGHAI 200032,China)

机构地区：[1]四川大学华西医院临床研究管理部,四川成都610041 [2]中国药科大学基础医学与临床药学学院,江苏南京210009 [3]艾昆纬医药科技(上海)有限公司,上海200032

出　　处：《中国新药与临床杂志》2021年第10期698-703,共6页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的调查分析公众对远程临床试验的接受度以及相关影响因素。方法采用在线问卷方式,以2020年6月至8月间来访华西医院的患者和人员为调查对象。调查人口学特征、临床试验经验、远程临床试验认知度,远程临床试验总体及相关环节的接受度及影响接受的原因等问题,并分析这些因素与公众接受度之间的关联性。结果共收集问卷700份,有效问卷685份(97.9%),其中304名(44.4%)受访者有临床试验经验。远程临床试验认知度高和具有临床试验经验与远程临床试验接受度高有显著关联性(P<0.05)。而性别、年龄、住所和受教育程度与远程临床试验接受度无显著关联性(P>0.05)。医护人员上门提供临床试验相关医疗服务(85.3%)、电子知情同意(85.8%)以及将药物直接运送到患者家(88.0%)的环节接受度较低。结论公众对远程临床试验的整体接受度较高。远程临床试验认知度较高或具有临床试验经验的公众,对远程临床试验接受度更高。AIM To investigate and analyze the public’s acceptance of remote clinical trials and related influencing factors.METHODS An online questionnaire was used to survey patients and caregivers who visited West China Hospital from June to August 2020.Questions included demographic characteristics,clinical trials experience,remote trials awareness,acceptance towards remote trials and its influencing factors.The relationship between these factors and public acceptance were analyzed.RESULTS A total of 700 questionnaires were collected,of which 685 were valid questionnaires(97.9%).And 304(44.4%)respondents had clinical trial experience.Higher recognition of remote clinical trials and having clinical trial experience were significantly associated with high acceptance of remote clinical trials(P<0.05).There was no significant correlation between genders,age,residence,education level and the acceptance of remote trials(P>0.05).Elements of site medical staff visiting patient home to provide trial related medical service(85.3%),electronic informed consent(85.8%)and investigational drug directly delivered to patient home(88.0%)were less accepted.CONCLUSION The public’s acceptance towards remote clinical trials is relatively high.And public who had high awareness towards remote clinical trials and experience in clinical trials had a higher acceptance towards remote clinical trials.

关 键 词：远程医学 临床试验 影响因素分析 调查和问卷 

分 类 号：R969.4[医药卫生—药理学]