Signal detection (SD) involves a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed.
With the growing importance of Risk management and Signal Detection for Pharmacovigilance, MAHs are expected to deploy state-of-the-art methodologies and look for best quality evidence to satisfy the needs and meet the expectation of regulators, patients and the public at large. With electronic data capture and electronic reporting becoming mandatory, there is a fast accruing safety dataset that needs to be reviewed in a structured and auditable manner.
Quantitative Signal Detection
It calculates the Proportional Reporting Ratio (PRR), upper bound – lower bound confidence intervals (CI’s) and also corresponding Chi-square values, for identifying statistical signals of disproportionate reporting.Once statistical signals are identified, the database allows clinical evaluation of each ICSR for the identified SDR (Signal of Disproportionate Reporting), thus differentiating true clinical signals from statistical noise or reporting artifacts.
Qualitative Signal Detection
In addition, during the initial assessment of ICSRS, PvEdge routinely flashes Targeted Medical Events (TME’s) and Adverse Events of Special Interest (AESI’s) as ‘to be monitored’ Drug – Event combinations, thus facilitating Index or Striking case method of Traditional Signal detection.