Signal Detection and PV-Works : Making Sense of Safety Data€¦ · PV-Analyser Data Mining and...

Assured Information Systems ; Signal Detection and PV-Works

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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.


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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


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• 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

veterinary pharmacovigilance.

For more information please contact us:

Phone +44 1480 21 22 23 Email: [email protected]

www.assured.co.uk

Signal Detection and PV-Works : Making Sense of Safety Data€¦ · PV-Analyser Data Mining and...

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