从分散的临床试验到分散的临床试验-in-a-box平台:朝着以患者为中心和公平的试验
Dorothy Dulko1,2, Manlik Kwong1,2, Marisha E Palm1,2
1Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Journal of clinical and translational science
|November 29, 2023
概括
分散的临床试验利用技术进行远程数据收集,增强参与者的多样性和安全性. 这种方法为未来的研究提供了一个灵活的模型,包括长COVID研究.
科学领域:
- 临床研究方法论临床研究方法论
- 数字健康技术是数字健康技术.
- 分散的临床试验 分散的临床试验
背景情况:
- 尽管具有直观的好处,但临床试验的分散招生并不普遍.
- 随着COVID-19的流行,临床研究中加速采用了分散的方法.
研究的目的:
- 描述二期COVID-19研究的分散临床试验的实施情况.
- 分享学到的经验教训,挑战和分散型模型的未来可能性,特别是长期COVID研究.
主要方法:
- 通过家用监控设备和移动应用程序利用实时数据采集和传输.
- 开发了一个分散的试验平台,用于患者参与和不良事件报告.
- 创建了一个"临床试验盒"工具,用于从去中心化平台收集和分析数据.
主要成果:
- 成功部署了一个用于COVID-19研究的去中心化试验平台.
- 该方法促进了远程数据收集和不良事件报告.
- 能够纳入来自不同社会经济背景和农村环境的参与者,同时减轻COVID-19传播风险.
结论:
- 使用数字健康和远程医疗的分散的临床试验,为研究提供了一个可行的模型,包括长期COVID.
- 这种方法提高了参与者可访问性和数据收集效率.
- 未来的研究可以在这些发现的基础上改进去中心化试验方法.
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