Assured Information Systems ; Signal Detection and PV-Works Page 1 of 3 Signal Detection and PV-Works : Making Sense of Safety Data Executive Summary Volume 9 clearly states that market authorisation holders have a responsibility to “ensure that all sources of information are screened regularly to identify potential signals and that appropriate action is taken in response to new evidence”. PV-Works offers a variety of tools to support signal detection ranging from simple reports through to a comprehensive statistics module. These can be incorporated into your pharmacovigilance process such that a regular review of safety profiles is conducted. It is recommended that this process is fully documented, even if the review detects no changes. Signal detection is likely to be a critical issue during pharmacovigilance inspection. Report-based Signal Detection All PV-Works users may run queries that search for cases that include particular clinical signs. While this may be appropriate to answer specific questions it is not a basis for efficient safety surveillance. In support of safety monitoring, PV-Works includes three crystal reports : a) AE report rate by product b) Clinical signs – multiple periods c) PRR statistics The first two provide incidence counts while the third converts these counts into a proportionality. Both incidence count reports are similar – one only considers a single time period (based on date received) while the other can compare across up to four date ranges. The date ranges are entered by the user at runtime.
Transcript
Assured Information Systems ; Signal Detection and PV-Works
Page 1 of 3
Signal Detection and PV-Works : Making Sense of Safety Data
Executive Summary
Volume 9 clearly states that market authorisation holders have a responsibility to “ensure that all
sources of information are screened regularly to identify potential signals and that appropriate action
is taken in response to new evidence”.
PV-Works offers a variety of tools to support signal detection ranging from simple reports through to
a comprehensive statistics module. These can be incorporated into your pharmacovigilance process
such that a regular review of safety profiles is conducted. It is recommended that this process is fully
documented, even if the review detects no changes. Signal detection is likely to be a critical issue
during pharmacovigilance inspection.
Report-based Signal Detection
All PV-Works users may run queries that search for cases that include particular clinical signs. While
this may be appropriate to answer specific questions it is not a basis for efficient safety surveillance.
In support of safety monitoring, PV-Works includes three crystal reports :
a) AE report rate by product
b) Clinical signs – multiple periods
c) PRR statistics
The first two provide incidence counts while the third converts these counts into a proportionality.
Both incidence count reports are similar – one only considers a single time period (based on date
received) while the other can compare across up to four date ranges. The date ranges are entered by
the user at runtime.
Assured Information Systems ; Signal Detection and PV-Works
Page 2 of 3
The PRR statistics report calculates the Proportional Reporting Ratio (PRR) for all products and signs
in a time period defined by the user. PRR is a widely used and well understood frequency measure of
disproportionality. It is the proportion of cases for a given product that are linked to a specific adverse
outcome, divided by the corresponding proportion for all other products. PRR is one of the key
methods used by EMA in safety monitoring.
PV-Analyser Data Mining and Signal Detection
PV-Analyser is Assured’s data mining and signal detection tool. It includes a flexible pivot table /
cube that can summarise data within categories defined by the user. PV-Analyser offers a complete
statistics module based on disproportionality methods, both with and without Bayesian inference.
PV-Analyser is ideal for companies with an extensive product portfolio or ones that wish to conduct
comprehensive quantitative safety surveillance of their data.
Statistical methods include:
• Proportional reporting ratio (PRR)
• Reporting odds ratio (ROR)
• Observed to expected ration (OE)
• Chi-squared significance
• Information content (IC)
• Empirical Bayesian geometric mean
(EBGM)
• Multi gamma poisson shrinker (MGPS)
Features of PV-Analyser include
• Analysis by product, ingredient and batch number
• Analysis at different MedDRA / VedDRA levels
• User defined alert thresholds with notification when these are exceeded
Assured Information Systems ; Signal Detection and PV-Works
Page 3 of 3
• Comparison of incidence of labelled and unlabelled terms
• Analysis of product interactions
• Stratification of analyses by multiple factors
• Analysis by time period
• Graphical and tabular output
• Export of data / results to Excel, SAS etc
• Data clean up
PV-Analyser is a logical extension of PV-Works for comprehensive signal detection and is licensed
by Assured as a separate product.
For further details please read the brochure below or contact us
Assured Information Systems provides comprehensive solutions for human and
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