A Decade of Data Mining and Still Counting

Excerpt

The introduction of database-wide disproportionality screening for signal detection in spontaneous reporting systems (SRS)[1] sparked a renaissance in pharmacovigilance research notable for numerous peer reviewed research articles, three expert working groups/white papers,[2‐4] countless meetings, symposia, workshops, graduate school theses and aggressive promotion of proprietary software. In addition to expanding the pharmacovigilance toolkit, this research has yielded ancillary benefits beyond patient safety, including an increased awareness of data quality issues such as case report duplication,[5,6] the importance of adverse event coding terminology,[7,8] the proper definition of signal in drug safety,[9] the logic of signal detection [10] and an admonition that conflicts of interest, both intellectual and financial, may not only involve the ‘usual suspects’ such as software vendors, but also other stakeholders that may not normally come to mind, such as regulatory authorities.[11] …