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在实用随机临床试验中使用案例研究进行数据和安全监测的指南

David Zahrieh¹, Ivana T Croghan², Jonathan W Inselman³

¹Department of Data Sciences and Development Strategy, Ultragenyx Pharmaceutical, Novato, CA; Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN.

Mayo Clinic proceedings

|November 3, 2023

概括

本研究为实用随机临床试验 (pRCT) 数据和安全监测提供了实际指导方针. 它为通用医生及其数据和安全监测委员会 (DSMB) 提供了关于报告和审查流程的明确建议.

科学领域:

临床试验临床试验
医疗保健服务研究医疗服务研究
数据监控数据监控

背景情况:

实用随机临床试验 (pRCT) 由于非传统的设计和现实世界的数据收集,提出了独特的数据和安全监测挑战.
现有的关于监测和向pRCT中的数据和安全监测委员会 (DSMBs) 报告的通用专家的实际指南是有限的.

研究的目的:

为一般医生和医疗从业者提供pRCT数据和安全监测的实用指南.
澄清在pRCT过程中应该监控和报告给DSMB的数据.
指导DSMB在pRCT报告中审查的关键领域.

主要方法:

在三个案例研究的背景下,讨论数据和安全监测方面的考虑.
专注于关键数据和安全监测问题,这些问题与进行pRCT的通用学家有关.
包含表格和图形插图,用于向DSMB展示数据.

主要成果:

确定关键数据和安全监测问题,用于pRCT中的通用专家.
展示有效的方法,以向DSMBs呈现累积数据.
在报告审查期间强调DSMB关注的具体领域.

结论:

这篇文章提供了实用策略和观点,用于有效的数据和pRCTs安全监测.
它是进行pRCT的通用学家的宝贵资源,增强DSMB审查流程.
改进数据呈现和专注的DSMB审查可以促进pRCTs的知情决策.

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