公众对临床试验的认知、实践与态度的调查研究

目的评价公众的临床试验的认知、实践与态度。方法采用匿名的横断面在线调查,共收集702份18岁以上中国公众的有效调查问卷。结果在702名被调查者中,有84.2%听说过临床试验,但是仅有6.0%作为受试者参与过药物临床试验。83.6%的被调查者知道“受试者的隐私和个人信息应该得到充分保护”,仅48.4%的被调查者知道“患者也可以参与设计和发起符合自己需要的临床试验”。41.7%的被调查者“愿意作为志愿者参加临床试验”。回归分析表明“工作/专业领域”“是否作为受试者参与过药物临床试验”“是否有亲人朋友作为受试者参与过药物临床试验”是影响公众参与临床试验意愿的显著因素。结论公众对临床试验的认知程度尚可,但是对于以患者为中心的临床试验发展趋势认识较低。公众的临床试验参与意愿较低,并且受自身专业背景以及相关经历影响很大。有必要开展针对公众的临床试验科普活动,积极发展临床试验公益团体,提升公众临床试验认知水平和参与积极度。

Investigation and Research on the Public's Cognition,Practice and Attitude towards Clinical Trials

Objective To evaluate the public's cognition,practice and attitude of clinical trials.Methods An anonymous cross-sectional online survey was used to collect a total of 702 valid questionnaires for the Chinese public over 18 years of age.Results Among 702 respondents,84.2%had heard of clinical trials,but only 6.0%had participated in drug clinical trials as subjects.83.6%of the respondents knew that"the privacy and personal information of the subjects should be fully protected",and only 48.4%of the respondents knew that"patients can also participate in the design and launch of clinical trials that meet their own needs."41.7%of the respondents were"willing to participate in clinical trials as volunteers".Regression analysis showed that"work/professional field""have you participated in drug clinical trials as subjects",and"have your relatives and friends participated in drug clinical trials as subjects"are significant factors affecting the public's willingness to participate in clinical trials.Conclusion The public's awareness of clinical trials is fair,but the understanding of the development trend of patient-centered clinical trials is low.The public's willingness to participate in clinical trials is low and is greatly affected by their professional background and related experience.It is necessary to carry out popularization of clinical trial science activities for the public,actively develop clinical trial public welfare groups,and enhance the public's awareness of clinical trials and their participation in clinical trials.