美国分散临床试验的参与者和场所认知的比较
Roland Barge1, Patrick Floody2
1Regeneron Pharmaceuticals, Uxbridge, Middlesex, United Kingdom.
Mayo Clinic proceedings. Digital health
|June 26, 2025
概括
参与者对分散的临床试验 (DCT) 比临床场所更为舒适. 这两个群体都获得了适当的支持的信心,但网站更担心负担和信任,强调需要明确的DCT指导.
科学领域:
- 临床研究方法论临床研究方法论
- 在试验中参与患者参与.
- 医疗保健技术采用 医疗保健技术采用
背景情况:
- 分散临床试验 (DCT) 正在通过减少场所负担和增加患者访问来改变研究.
- 了解利益相关者的看法对于成功实施DCT至关重要.
- 现有的研究往往侧重于技术,而不是人类因素.
研究的目的:
- 定义潜在的参与者和地点对分散的临床试验 (DCT) 的看法.
- 从患者和现场的角度确定DCT采用的关键问题和促进者.
- 为DCT提供支持框架的发展提供信息.
主要方法:
- 在2022年1月至2022年8月期间进行了两次定性调查.
- 调查1:141临床试验现场工作人员的回答.
- 调查2:来自美国的健康个人或患有疾病的人的481个回答.
主要成果:
- 与现场相比,参与者在混合和远程试验中表现出更大的舒适度.
- 现场工作人员比参与者更担心负担,信任和安全问题.
- 两组人都对有足够支持的远程活动充满信心;随着感知到负担,使用技术的意愿下降.
结论:
- 参与者和现场对DCT的看法存在显著差异.
- 解决现场问题和参与者负担是成功实施DCT的关键.
- 有效的DCT框架需要合作开发和明确的监管指导.
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