ABSTRACT

A Data Monitoring Committee (DMC) evaluates patient safety in a clinical trial of an investigational intervention through periodic review of adverse events (AEs) and clinical safety assessments. Our aim was to construct DMC report displays to enhance the DMC safety review through use of graphics and clear identification and adjustment for missing data caused by early discontinuations and ongoing study participation. Suggested displays include a study snapshot graph, enhanced adverse event incidence tables including the incidence density and plotted incidence proportions, line graphs in place of by-patient listings, and trend plots in place of tables for continuous assessments.

摘要

数据监测委员会 (DMC) 通过定期审查不良事件 (AE) 和临床安全评估来评估研究干预临床试验中的患者安全。我们的目标是构建 DMC 报告显示，通过使用图形和清晰识别和调整因早期中断和正在进行的研究参与导致的缺失数据来增强 DMC 安全审查。建议的显示包括研究快照图、增强的不良事件发生率表（包括发生率密度和绘制的发生率比例）、代替患者列表的折线图以及代替连续评估表格的趋势图。