论文标题
药物安全的数据科学方法:疼痛治疗临床试验的不良药物事件的语义和视觉挖掘
A data science approach to drug safety: Semantic and visual mining of adverse drug events from clinical trials of pain treatments
论文作者
论文摘要
临床试验是循证医学的基础。试验结果由专家和共识小组审查,以生成荟萃分析和临床实践指南。但是,审查这些结果是一项漫长而繁琐的任务,因此,每次发布新试验时,都不会更新荟萃分析和准则。此外,专家的独立性可能很难评估。相反,在许多其他领域,包括医学风险分析,数据科学的出现,大数据和视觉分析允许从基于专家的知识转移到基于事实的知识。自12年以来,许多试验结果都可以在试用注册表中在线公开获得。然而,数据科学方法尚未广泛应用于试验数据。在本文中,我们提出了一个平台,用于分析在临床试验期间报告的安全事件,并在试验注册表中发布。该平台基于一个本体论模型,其中包括582个有关疼痛治疗的试验,并使用语义Web技术以各种粒度级别查询该数据集。它还依靠26维花字形来可视化13个类别和2个严重程度的不良药物事件(ADE)率。我们通过几种用例说明了该平台的兴趣,我们能够找到最初在荟萃分析中发现的结论。该平台已介绍给四名药物安全专家,并在网上公开获得疼痛治疗的本体。
Clinical trials are the basis of Evidence-Based Medicine. Trial results are reviewed by experts and consensus panels for producing meta-analyses and clinical practice guidelines. However, reviewing these results is a long and tedious task, hence the meta-analyses and guidelines are not updated each time a new trial is published. Moreover, the independence of experts may be difficult to appraise. On the contrary, in many other domains, including medical risk analysis, the advent of data science, big data and visual analytics allowed moving from expert-based to fact-based knowledge. Since 12 years, many trial results are publicly available online in trial registries. Nevertheless, data science methods have not yet been applied widely to trial data. In this paper, we present a platform for analyzing the safety events reported during clinical trials and published in trial registries. This platform is based on an ontological model including 582 trials on pain treatments, and uses semantic web technologies for querying this dataset at various levels of granularity. It also relies on a 26-dimensional flower glyph for the visualization of the Adverse Drug Events (ADE) rates in 13 categories and 2 levels of seriousness. We illustrate the interest of this platform through several use cases and we were able to find back conclusions that were initially found during meta-analyses. The platform was presented to four experts in drug safety, and is publicly available online, with the ontology of pain treatment ADE.