Perspectives on the use of data mining in pharmacovigilance
Perspectives on the use of data mining in pharmacovigilance
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DOI：
10.2165/00002018-200528110-00002
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发表时间：
2005-01-01
期刊：
影响因子：
4.2
通讯作者：
LaCroix, K
中科院分区：
文献类型：
--
作者：
Almenoff, J;Tonning, JM;LaCroix, K
在过去的5年里，监管机构和药物监测中心一直在开发计算机化的数据挖掘方法，以更好地识别自发报告数据库中可能表明可能的药物不良反应的报告关系。目前，在常规药物警戒中使用这些方法还没有指导方针或标准。2003年，一群来自制药业和美国FDA的统计学家、药物流行病学家和药物警戒专业人员组成了美国药品研究和制造商安全评估工具合作工作组，以审查使用这些方法的最佳实践。在本文中，我们概述了：(I)当前使用的几种方法的统计和操作属性及其优点和局限性；(Ii)关于这些工具可用于部署的各种上市后安全数据库的特征的信息；(Iii)使用安全数据挖掘方法和解释结果的分析考虑；以及(4)将安全数据挖掘与传统药物警戒方法相结合时需要考虑的问题。数据挖掘是传统药物警戒方法的一种潜在有用的辅助手段。数据挖掘的结果应被视为假设生成，并应结合其他相关数据进行评估。提供一个可供公众查阅的、经常更新的全球安全数据库，将进一步加强对安全问题的发现和交流。
In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine pharmacovigilance. In 2003, a group of statisticians, pharmacoepidemiologists and pharmacovigilance professionals from the pharmaceutical industry and the US FDA formed the Pharmaceutical Research and Manufacturers of America-FDA Collaborative Working Group on Safety Evaluation Tools to review best practices for the use of these methods.In this paper, we provide an overview of: (i) the statistical and operational attributes of several currently used methods and their strengths and limitations; (ii) information about the characteristics of various postmarketing safety databases with which these tools can be deployed; (iii) analytical considerations for using safety data-mining methods and interpreting the results; and (iv) points to consider in integration of safety data mining with traditional pharmacovigilance methods. Perspectives from both the FDA and the industry are provided.Data mining is a potentially useful adjunct to traditional pharmacovigilance methods. The results of data mining should be viewed as hypothesis generating and should be evaluated in the context of other relevant data. The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues.