有多少证据是足够的? 研究赞助商的经验 寻求监管机构对数字健康技术衍生终点的接受
Brian Perry1,2, Lindsay Kehoe1,3, Teresa Swezey1,2
1Clinical Trials Transformation Initiative, Durham, NC, USA.
Digital biomarkers
|July 5, 2023
概括
数字健康技术 (DHT) 提供实时患者数据,但在临床试验中对标签索赔的使用有限. 关键的挑战包括监管的明确性,不切实际的资格程序,以及缺乏验证的DHT和供应商支持.
科学领域:
- 数字健康数字健康
- 临床试验 临床试验
- 监管科学 监管科学
背景情况:
- 数字健康技术 (DHT) 能够实时评估患者的功能.
- 目前在临床试验中用于产品标签的DHT衍生终点的使用受到限制.
研究的目的:
- 在临床试验中探索赞助商与DHT衍生终点的经验.
- 确定在关键试验中使用DHT衍生终点的障碍和建议.
主要方法:
- 使用与临床试验赞助人的半结构面试进行的定性描述性研究 (2020年11月至2021年3月).
- 应用专题分析以确定挑战并提供建议.
主要成果:
- 确定了五个主要挑战:监管的明确性,不切实际的资格,缺乏对比终点,缺乏经过验证的DHT/算法,以及供应商支持不足.
- 调查结果与监管机构 (FDA,EMA) 和利益相关者分享.
结论:
- 提供了新的和修订的工具,以帮助赞助商利用DHT衍生的终点来进行关键试验标签索赔.
- 解决已确定的挑战对于在药物开发中更广泛地采用DHT至关重要.
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