Novel statistical tools for monitoring the safety of marketed drugs
Novel statistical tools for monitoring the safety of marketed drugs
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DOI：
10.1038/sj.clpt.6100258
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发表时间：
2007-08-01
影响因子：
6.7
通讯作者：
Yuen, N.
中科院分区：
文献类型：
--
作者：
Almenoff, J. S.;Pattishall, E. N.;Yuen, N.
用于监测市面上销售的治疗产品安全性的强有力的工具对公众健康至关重要。近年来，开发了创新的统计方法来筛选大型上市后安全数据库，以发现发生频率不成比例的不良事件(AEs)。这些方法被称为定量信号检测、不相称性分析或安全数据挖掘，有助于识别新的安全问题或产品可能的有害影响。在本文中，我们描述了这些方法背后的统计学概念，以及它们在使用自发声发射报告监测药品安全性方面的实际应用。我们还提供了如何使用这些工具来识别新的药物相互作用和药物不良反应的人口风险因素的例子。讨论了未来研究的挑战、争议和前沿。
Robust tools for monitoring the safety of marketed therapeutic products are of paramount importance to public health. In recent years, innovative statistical approaches have been developed to screen large post- marketing safety databases for adverse events (AEs) that occur with disproportionate frequency. These methods, known variously as quantitative signal detection, disproportionality analysis, or safety data mining, facilitate the identification of new safety issues or possible harmful effects of a product. In this article, we describe the statistical concepts behind these methods, as well as their practical application to monitoring the safety of pharmaceutical products using spontaneous AE reports. We also provide examples of how these tools can be used to identify novel drug interactions and demographic risk factors for adverse drug reactions. Challenges, controversies, and frontiers for future research are discussed.