潜在受试者对药物临床试验认知的调查

Prevalence Survey of Cognition of Potential Participants for Clinical Trials

目的对潜在受试者药物临床试验知晓状况、参与意愿及影响因素等内容进行调查,为药物临床试验工作的开展提供指导。方法自行设计调查问卷,随机选择某三甲医院内科、外科、妇产科门诊患者进行匿名问卷调查,对结果进行统计分析。结果回收有效问卷1 067份,调查对象对药物临床试验总知晓率为31.02%,年龄与文化程度是知晓与否的影响因素。40.86%的调查对象愿意参与药物临床试验,为医学进步贡献力量为主要参与动机,占55.28%,药物临床试验知晓者更倾向于参与药物临床试验(OR:1.361,95%CI:1.042-1.777)。59.14%调查对象拒绝参与药物临床试验,其中68.62%拒绝的主要原因为担心药物的安全性;57.37%调查对象表示如果有专家参与,有医生负责则会改变意愿。41.33%的调查对象愿意接受相关知识培训。结论调查对象药物临床试验知晓率与其参与药物临床试验的意愿密切相关,应契合公众需求开展针对性宣传。

ObjectiveTo investigate the awareness, willingness, motivation, and influencing factors of outpatients for participating drug clinical trials, and provide references for decision-making of drug clinical trials. MethodsAn anmonymous survey was conducted in the departments of internal medicine, surgery, gynecology, and obstetrics of a randomly selected tertiary referral center, and the results were statistically analyzed. ResultsA total of 1 067 available questionnaires were received. The total awareness rate of clinical trials was 31.02%, which was closely correlated with age and the degree of education. 40.86% of respondents were willing to participate in drug clinical trials. And 55.28% of them chose yes because of the willingness to contribute to the development of medical science. People having cognition on clinical trials had more willingness to participate in drug（OR：1.361,95%CI：1.042-1.777）.59.14% of the respondents refused to participate in drug clinical trials, 68.62% of whom refusing to participate mainly worried about the safety of drugs. 57.37% of the respondents comfirmed that they might change their idea if experts were involved. 41.33% were willing to accept training about clinical trials. ConclusionInvestigators＇ overall cognition on clinical trials is closely correlated with the willingness to participate in drug clinical trials. There should propagandize drug clinical trials to make sure the improvement of drug clinical trial progress.