Choi Yun Jung, Beck Sung-Ho, Kang Woon Yong, Yoo Soyoung, Kim Seong-Yoon, Lee Ji Sung, Burt Tal, Kim Tae Won
Asan Medical Center, Clinical Trial Center, Seoul, Korea .
Asan Medical Center, Human Research Protection Center, Seoul, Korea .
J Korean Med Sci. 2016 May;31(5):674-81. doi: 10.3346/jkms.2016.31.5.674. Epub 2016 Mar 15.
Considering general public as potential patients, identifying factors that hinder public participation poses great importance, especially in a research environment where demands for clinical trial participants outpace the supply. Hence, the aim of this study was to evaluate knowledge and perception about clinical research in general public. A total of 400 Seoul residents with no previous experience of clinical trial participation were selected, as representative of population in Seoul in terms of age and sex. To minimize selection bias, every fifth passer-by was invited to interview, and if in a cluster, person on the very right side was asked. To ensure the uniform use of survey, written instructions have been added to the questionnaire. Followed by pilot test in 40 subjects, the survey was administered face-to-face in December 2014. To investigate how perception shapes behavior, we compared perception scores in those who expressed willingness to participate and those who did not. Remarkably higher percentage of responders stated that they have heard of clinical research, and knew someone who participated (both, P < 0.001) compared to India. Yet, the percentage of responders expressed willingness to participate was 39.3%, a significantly lower rate than the result of the India (58.9% vs. 39.3%, P < 0.001). Treatment benefit was the single most influential reason for participation, followed by financial gain. Concern about safety was the main reason for refusal, succeeded by fear and lack of trust. Public awareness and educational programs addressing these negative perceptions and lack of knowledge will be effective in enhancing public engaged in clinical research.
将普通公众视为潜在患者,识别阻碍公众参与的因素至关重要,尤其是在临床试验参与者需求超过供应的研究环境中。因此,本研究的目的是评估普通公众对临床研究的知识和认知。总共选取了400名此前没有参与过临床试验的首尔居民,他们在年龄和性别方面代表了首尔的人口。为尽量减少选择偏倚,每隔五名路人被邀请进行访谈,如果是在一群人中,则询问最右边的人。为确保调查的统一使用,问卷中添加了书面说明。在对40名受试者进行预试验后,于2014年12月进行了面对面调查。为了研究认知如何塑造行为,我们比较了表示愿意参与和不愿意参与的人的认知得分。与印度相比,显著更高比例的受访者表示他们听说过临床研究,并且认识参与过的人(两者,P < 0.001)。然而,表示愿意参与的受访者比例为39.3%,明显低于印度的结果(58.9%对39.3%,P < 0.001)。治疗益处是参与的最主要影响因素,其次是经济收益。对安全性的担忧是拒绝的主要原因,其次是恐惧和缺乏信任。针对这些负面认知和知识缺乏的公众意识和教育项目将有效地提高公众参与临床研究的程度。