在数字化措施开发中以患者为中心:最佳实践和监管指导的共同发展
Suvekshya Aryal1, Jennifer M Blankenship2, Shelby L Bachman2
1VivoSense Inc, Newport Coast, CA, USA. suvekshya.aryal@vivosense.com.
NPJ digital medicine
|May 16, 2024
概括
数字健康技术 (DHT) 通过收集以患者为中心的数据,可以改善药物开发. 证明这些数字措施对患者的意义仍然是获得监管批准的关键挑战.
科学领域:
- 数字健康数字健康
- 临床结果评估临床结果评估
- 药物开发 药物开发
背景情况:
- 数字健康技术 (DHT) 提供了在药物开发中远程,连续收集数据的潜力.
- 来自DHT的证据可以加强治疗批准和改善患者生活之间的联系.
- 很少有新的数字措施取得了监管资格或有效性终点的进展.
研究的目的:
- 检查美国监管指导和最佳实践的共同发展,以将DHT整合到临床结果评估中.
- 审查FDA关于制定有意义的数字措施和患者参与的指导和文献.
- 在以患者为中心的药物开发范式中对数字措施的发展进行上下文化.
主要方法:
- 审查美国食品和药物管理局 (FDA) 关于数字措施的指导.
- 对开发有意义的数字措施和患者参与的现有文献进行分析.
- 检查最近的FDA拒绝,突出数字措施中以患者为中心.
主要成果:
- 向患者展示数字措施的意义是监管协议的一个重大障碍.
- 最近的FDA拒绝强调了以患者为中心在数字测量开发中的关键重要性.
- 在DHT的潜力和其当前作为监管终点的采用之间存在差距.
结论:
- 将DHT整合到药物开发中需要克服监管资格方面的挑战,并证明患者的意义.
- 患者参与和遵守监管指南对于成功采用数字措施至关重要.
- 需要建立框架和进一步的洞察力,以促进DHT在临床研究中的开发和采用.
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