A curated and standardized adverse drug event resource to accelerate drug safety research.
A curated and standardized adverse drug event resource to accelerate drug safety research.
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DOI：
10.1038/sdata.2016.26
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发表时间：
2016-05-10
期刊：
影响因子：
9.8
通讯作者：
Shah NH
中科院分区：
文献类型：
--
作者：
Banda JM;Evans L;Vanguri RS;Tatonetti NP;Ryan PB;Shah NH
药品上市后阶段的不良反应（ADR）识别是药品安全性监测的重要目标之一。自发报告系统（SRS）的数据，这是传统的药物安全性监测的支柱，用于假设生成和验证新的方法。公开的美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据在适当使用之前需要大量的管理，并且应用不同的数据清理和标准化策略可能会对分析结果产生重大影响。我们提供了FAERS的策划和标准化版本，删除重复的病例记录，应用标准化词汇表，将药物名称映射到RxNorm概念，将结果映射到SNOMED-CT概念，并预先计算一般消费的药物-结果关系的汇总统计数据。这一公开可用的资源，沿着源代码，将通过减少对源FAERS报告执行数据管理所花费的时间，提高基础数据的质量，并使用通用词汇进行标准化分析，来加速药物安全性研究。
Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies.