Traditional methods of signal detection

Traditional pharmacovigilance approaches are particularly important in the assessment of designated medical events (DMEs – Adverse events which are rare, serious have a high drug attributable risk distributed over multiple distinct pharmacological/therapeutic classes) or rare events for which clinical evaluation of individual cases tends to carry a larger weight and for which there may be an especially high premium on sensitivity over specificity.

Traditional pharmacovigilance methods for analysis of adverse event reports include:
● Review of individual cases or case series in a pharmacovigilance database or in published medical or scientific literature; and
● Aggregate analyses of case reports using absolute case counts, simple reporting rates or exposure-adjusted reporting rates.

Traditional methods include both qualitative (e.g. manual medical review of individual cases or case series) and simple quantitative approaches (e.g. frequency/reporting rates, sorting, cross-tabulation etc.). Qualitative review of ICSR is critical method of detection for events where the background incidence is uncommon or rare and should not be replaced by quantitative methods.

Simple graphical representation of safety signal: