Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Dec 2018
Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA.
Data mining has been introduced as one of the most useful methods for signal detection by spontaneous reports, but data mining is not always effective in detecting all safety issues. To investigate appropriate situations in which data mining is effective in routine signal detection activities, we analyzed the characteristics of signals that the US Food and Drug Administration (FDA) identified from the FDA Adverse Event Reporting System (FAERS). ⋯ Data mining was shown to be effective in the following situations: (1) early detection of safety issues for newly marketed drugs, (2) continuous monitoring of safety issues for old drugs, and (3) signal detection of nonserious AEs, to which little attention is usually given.