一项来自2029位受访者对临床试验认知度与参与度的调查研究

A survey of cognition and participation to clinical trials from 2029 respondents

目的了解公众对临床试验认知度与参与意愿的现状,为提高我国公众对临床试验的认知度及参与度提供参考依据。方法本研究采用电子问卷形式,国内共43家医疗机构参与调研,来院就诊的患者、家属等通过扫码参加匿名线上问卷调查。收集的数据以描述性为主,对认知度得分进行二分类,得分大于等于4为良好。用SAS9.4软件进行统计分析,关于参与度,采用频率描述法进行分析。结果本次调查共有2029例公众参与,共收集到2029份有效问卷。关于临床试验认知度多因素分析显示,年龄、学历、职业,关注医学节目的频率,是否有从事医疗卫生行业工作的亲友和是否拥有保险是公众认知度的影响因素。临床试验参与度方面,52.8%的受访对象表示愿意参与临床试验。其中最主要动机为得到最前沿的治疗方法,占比为67.7%,其次为获得免费的药物及检查,占比62.2%,得到更好的医疗服务,占比54.5%;11.7%的调查对象不愿意参与临床试验,拒绝的首要原因为担心新药副作用太大,占比63.4%,其次为对新药疗效未知的担心,占比59.2%。结论本次研究表明相较既往研究,公众对临床试验的认知度有一定提高,但参与度仍有提升空间,应契合公众需求,开展针对性的宣传,加强知情同意告知的充分性,提高公众参与临床试验的积极性。

Objective This study assessed public knowledge of and willingness to participate in clinical trials and to provide evidence for improvement measures.Methods This study was conducted in the form of electronic questionnaire and an anonymous online questionnaire survey was carried out by patients and their family members in 43 hospitals in China.The collected data were mainly descriptive,and the cognition score was classified into two categories,and the score greater than or equal to 4 was considered good the survey data were exported and statistically analyzed by SAS9.4,with regard to engagement,frequency description method is used for analysis.Results A total of 2029 people participated in this online survey,and a total of 2029 valid questionnaires were collected.As for awareness of clinical trials,multivariate analysis showed that age,education,occupation,frequency of watching medical programs,whether you have relatives or friends who work in the health care industry and whether you have insurance are the factors affecting public awareness.In the terms of participation,52.8%of participants indicated their willingness to take part in clinical trials and top reasons were the cutting edge of treatment(67.7%),followed by free medicines and examinations(62.2%)and better medical care services(54.5%).The survey also found that 11.7%of respondents were unwilling to participate in clinical trials and main reasons were concerned about the risk to their own health(63.4%)and not being convinced about the outcome and benefits of clinical trials(59.2%).Conclusion Public’s knowledge on clinical trials has generally improved but willingness to taking part in clinical trials is still low.Researchers and the government should meet the needs of the public,strengthen the popularization of clinical trials,fully informed consent and increase the public’s enthusiasm for participating in clinical trials.