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Signal detection is an essential pharmacovigilance (PV) activity designed to support patient safety by actively uncovering potential safety risks in medical drugs and vaccines. For post-market products, the status quo for signal detection involves monitoring individual case safety reports (ICSR) and literature from multiple sources.Since the turn of the century, organizations have relied on ICSR data for signal detection. Whether used to report product problems, adverse events or consumer complaints, ICSRs provide information integral to medicinal products’ safety.
When the system flags a disproportionate number of adverse events (AEs) for a product, highly trained safety scientists or risk physicians on the PV signal team analyze underlying cases and other available evidence. They use this information to determine a possible causal relationship between the AEs and related…