收集和分析软件作为医疗器械的坚持信息 临床试验:系统审查
Emily Grayek1, Tamar Krishnamurti2, Lydia Hu1
1Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA, United States.
JMIR mHealth and uHealth
|November 15, 2023
概括
数字健康应用程序试验缺乏一致的遵守报告和适当的疗效分析. 改进这些标准对于准确评估软件作为医疗器械 (SaMD) 的有效性至关重要.
科学领域:
- 数字健康数字健康
- 监管科学 监管科学
- 临床试验 临床试验
背景情况:
- 数字健康应用程序需要强有力的监管监督,以确保安全和有效性.
- 不遵守和用户参与的多样性可能会扭曲数字健康干预的试验结果.
- 目前缺乏用于测量效果分析中的坚持和减轻偏差的标准.
研究的目的:
- 评估软件作为医疗器械 (SaMD) 应用程序在临床试验中的遵守和参与指标的报告.
- 评估用于解决SaMD试验中不遵守的有效性分析的适当性.
主要方法:
- 对食品和药物管理局注册的,面向患者的SaMD疗法及其临床试验的系统审查.
- 分析了24篇文章,使用基于Cochrane偏见风险标准的框架.
- 合并,参与和有效性分析数据的总结和分析.
主要成果:
- 大多数文章 (96%) 收集了参与数据,但只有45%报告了对处方使用的全面遵守.
- 报告的启动,实施和持续性指标存在显著差异.
- 大多数试验中的有效性估计可能因不遵守偏见,很少有人 (10%) 使用适当的有效性分析方法.
结论:
- 未来的SaMD试验需要一致和可靠的遵守指标.
- 建议预先注册分析和较少偏见的疗效分析方法.
- 关于统计方法和假设的完整报告对于SaMD试验透明度至关重要.
关键词:
坚持性 坚持性申请申请表 申请表 申请表临床试验是指临床试验中的临床试验.符合合规性的合规性是什么有效性 有效性.有效性 有效性 有效性.参与 参与 参与 参与评价 评价 评价 评价移动健康 移动健康 移动健康 移动健康医疗器械 医疗器械是一种医疗器械.移动健康的移动健康危险的风险 危险的风险在安全方面,安全是安全的.系统性审查 系统性审查可用性可用性可用性更多相关视频
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