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使用JMP Clinical进行临床试验安全性数据分析可视化的优势_姚晨教授 (Prof. Chen Yao)


Speaker:Chen Yao, Professor, Peking University First Hospital


主题:使用JMP Clinical进行临床试验数据分析可视化的优势

Topics: The Advantages of Using JMP® Clinical for Clinical Data Analysis Visualization


探讨可视化方法在临床试验不良事件和实验室检测数据分析中的应用。方法: 根据国际协调会议(International Conference on Harmonization,ICH) 有关药物安全性评价指南要求,我们使用JMP Clinical对临床试验中的真实的不良事件和实验室检测数据分析,进行可视化绘图,比较不良事件发生的组间差异,突出需重点关注的不良事件。 利用时间趋势,比较组间分布来理解实验室检测数据。结果: 文中绘制多幅图,如火山图, 韦恩图、生存图, 相对风险图,视箱式图,二维散点图,动态泡泡图和受试者个人档案图。结论: 不良事件数据的可视化评价不仅能描述不良事件特征,还能突出显示应引起重视的不良事件。同样,实验室检测数据的可视化评价,不仅能描述数据特征,还能突出显示应引起重视的个体数据。在临床试验实验数据分析中应当优先考虑使用。



The objective of this presentation is to evaluate a visual approach in the analysis of adverse events and laboratory data from clinical trials. According to the International Conference on Harmonization (ICH) for the drug safety evaluation guide, we use JMP Clinical to analyze real adverse events and laboratory data in clinical trials, and visualize the data. The incidences of adverse events between groups were compared. The important adverse events were identified and studied in detail. We displayed time trends, and compared the distribution between groups to understand the laboratory test data. We illustrated multiple specific graphs and visualizations, such as the volcano plot, Venn diagram, survival plot, relative risk plot, box plot, two-dimensional arrays of scatterplots, dynamic bubble plot and patient profile. Not only can visualization of adverse event data describe characteristics, but it can also highlight which adverse events should receive attention. Similarly, the visualization of laboratory data can describe not only the data characteristics, but also highlight the individual data that should be noticed. Visualization should be recommended for clinical trial data analysis.

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