Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials
Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials
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DOI：
10.1001/jamanetworkopen.2018.2969
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发表时间：
2018-10-01
影响因子：
13.8
通讯作者：
Getz, Kenneth
中科院分区：
文献类型：
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作者：
Anderson, Annick;Borfitz, Deborah;Getz, Kenneth
重要性 患者参与的有效、持续改进取决于对临床研究中公众和患者看法和经验的深入了解。 目的 确定临床试验参与者和非参与者的观点，并描述这些观点随时间变化的趋势。 设计、设置和参与者 在这项调查研究中，临床研究参与信息和研究中心于 2017 年 5 月 8 日至 7 月 24 日在线进行了一份调查问卷 (CISCRP)，并将结果与 2013 年和 2015 年进行的先前研究进行了比较。2017 年的样本包括来自 68 个国家的 12,427 名个人的回复，代表了 10% 的参与率。与 CISCRP 和其他组织进行的国际评估类似，本研究从方便样本中得出了答复；任何收到电子邮件或在线访问的 18 岁以上成年人都有资格参加。 主要结果和措施 与过去的 CISCRP 研究相比，公众和研究志愿者的看法和临床试验经历发生了显着变化。 结果 总共 12 427 人（平均 [SD] 年龄，55 [15] 岁；7355 名女性 [59.2%]；10 085 名[81.2%]白色）， 其中 2194 名（17.7%）参与过之前临床研究的人对 2017 年的调查做出了回应。调查结果表明他们相信临床研究的重要性，但对研究过程的了解仍然有限。 2017年，共有10506人（84.5%）认为临床研究对于新药的发现和开发非常重要；然而，6919 名受访者中有 4079 人 (59.0%) 无法说出进行研究的地点。共有11182名受访者（90.0%）认为临床研究总体安全；然而，12 427 人中的 5578 人 (44.9%) 报告说，在与医生讨论治疗或药物时很少考虑临床试验作为一种选择。参与临床试验被认为是不方便且繁重的；在最新的调查中，1075 名受访者 (49.0%) 表示，他们的临床试验参与扰乱了他们的日常生活。 结论和相关性 这项研究的结果可能为与公众和患者建立有意义和有效的参与奠定了基础，并揭示了障碍，包括公众之间的知识差距、医生参与讨论临床试验作为治疗选择的有限度，以及患者自愿参加临床试验后遇到的不便。 参加。这些发现可能会为患者参与策略和策略提供信息，并最终有助于加速药物开发过程。
IMPORTANCE Effective, continuous improvement in patient engagement depends on an intimate understanding of public and patient perceptions and experiences in clinical research.OBJECTIVES To identify the views of clinical trial participants and nonparticipants and characterize trends in these views over time.DESIGN, SETTING, AND PARTICIPANTS In this survey study, a questionnaire was administered online from May 8 to July 24, 2017, by the Center for Information and Study on Clinical Research Participation (CISCRP), and findings were compared with previous studies conducted in 2013 and 2015. The 2017 sample included responses from 12 427 individuals from 68 countries and represents a 10% participation rate. Similar to international assessments conducted by the CISCRP and other organizations, this study drew responses from a convenience sample; any adult older than 18 years who received an email or had online access was eligible to participate.MAIN OUTCOMES AND MEASURES Significant changes were observed in the perceptions and clinical trial experiences of the public and study volunteers compared with past CISCRP studies.RESULTS A total of 12 427 individuals (mean [SD] age, 55 [15] years; 7355 [59.2%] female; 10 085 [81.2%] white), 2194 (17.7%) of whom had participated in previous clinical research studies, responded to the survey in 2017. Findings indicated a belief in the importance of clinical research, but limited understanding of the research process persists. In 2017, a total of 10 506 individuals (84.5%) perceived clinical research to be very important to the discovery and development of new medicines; however, 4079 of 6919 respondents (59.0%) were unable to name a place where studies were conducted. A total of 11182 respondents (90.0%) believed that clinical research is generally safe; however, 5578 of 12 427 individuals (44.9%) reported that clinical trials are rarely considered as an option when discussing treatments or medications with their physician. Clinical trial participation was perceived as inconvenient and burdensome; in the latest survey, 1075 respondents (49.0%) expressed that their clinical trial participation disrupted their daily routine.CONCLUSIONS AND RELEVANCE The results of this study may provide a foundation from which to build meaningful and effective engagement with the public and patients and revealed roadblocks, including knowledge gaps among the public, limited physician involvement in discussing clinical trials as treatment options, and the inconveniences that patients encounter after they volunteer to participate. These findings may inform patient engagement strategies and tactics and ultimately help accelerate the drug-development process.