Thomas Sonia M, Jung Kwanhye, Sun Hengrui, Psioda Matthew A, Quibrera Pedro Miguel, Strakowski Stephen M
Division of Biostatistics and Epidemiology, RTI International, Research Triangle Park, NC, USA.
Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
J Biopharm Stat. 2020 Nov 1;30(6):1147-1161. doi: 10.1080/10543406.2020.1815034. Epub 2020 Sep 8.
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.
数据监测委员会（DMC）通过定期审查不良事件（AE）和临床安全性评估，来评估一项研究性干预措施临床试验中的患者安全性。我们的目标是构建DMC报告展示，通过使用图形以及对因早期停药和持续参与研究导致的缺失数据进行清晰识别与调整，来加强DMC的安全性审查。建议的展示内容包括研究快照图、增强的不良事件发生率表（包括发病密度和绘制的发病比例）、替代逐患者列表的线图，以及替代连续评估表格的趋势图。
