欧洲药品署关于数字健康技术衍生终点的见解
Keerti D Jadoenathmisier1, Helga Gardarsdottir2, Peter G M Mol3
1Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
Drug discovery today
|May 28, 2025
概括
数字健康技术 (DHT) 在临床试验中越来越多地用于终点测量. 欧洲药物管理局 (EMA) 的指南强调,需要对这些创新工具进行强有力的验证和明确的用例.
科学领域:
- 临床试验 临床试验
- 数字卫生技术数字卫生技术
- 监管科学 监管科学
背景情况:
- 数字健康技术 (DHT) 是临床研究中数据收集的新兴工具.
- 欧洲药品署 (EMA) 提供了关于在临床试验中使用DHTs的指导.
- 评估EMA的历史建议可以了解DHT采用趋势.
研究的目的:
- 分析欧洲药物管理局 (EMA) 对临床试验终点测量的数字健康技术 (DHT) 的反.
- 从2013年到2022年,确定DHT提案和监管考虑的趋势.
- 了解EMA关于DHT在药物开发中的验证和应用的观点.
主要方法:
- 系统审查EMA的资格意见,资格建议和科学建议文件.
- 分析DHT类型,建议的治疗领域和终端应用.
- 对EMA关于验证,准确性和使用背景的反进行主题分析.
主要成果:
- 加速度计是最常被提议的DHT,其次是血糖计和智能手机.
- 主要建议DHT用于疗效终点,特别是在神经系统疾病试验中用于移动性测量.
- 欧洲药物管理局的反始终强调了对DHT的验证,准确性和定义的使用上下文的关键重要性.
结论:
- 欧洲药物管理局积极支持将DHT纳入临床试验,强调严格的方法标准.
- 监管指南不断发展,反映了DHT在生成客观和可靠的临床试验数据方面日益增长的作用.
- 未来的临床试验可能会看到验证的DHT的使用增加,这是由于监管机构的接受和技术进步所推动的.
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