The document outlines the signal management process including detection, validation, analysis, and tracking of safety signals in pharmacovigilance from September 29 to 30, 2016, in Frankfurt. It highlights challenges in data mining, such as selection bias and the influence of unverified data sources, and compares qualitative and quantitative assessment methods for Individual Case Safety Reports (ICSRs). Additionally, it references statistical methodologies like the proportional reporting ratio and the empirical Bayesian geometric mean for identifying drug-event associations.

1. Detect the safety signals
Signal Detection & Management Strategies
29th September - 30th September 2016, in Frankfurt
1 Signal management process
The signal management process shall
include all steps from initial signal
detection; through their validation and
confirmation; analysis and prioritisation;
and signal assessment to recommending
action, as well as the tracking of the
steps taken and of any
recommendations made.
SignalDetection
Signal
Prioritization
Signal
Evaluation
2 Challenges in data mining
Data mining posing challenges which must be taken
into consideration.
One particular challenge is selection bias, when the
reporters are in control of what actually gets
reported. This could lead to an over-representation
or under-representation of the true data. Reporting
can also be influenced by social media attention that
may or may not be a true representation of a drug
event association.
The source data is sometimes unverified and
consumers self-diagnosing can also skew the data.
True or false?
3
Qualitative vs. quantitative
assessment of ICSRs
Case-by-case manual review of individual case reports (a single
case, in some rare instances, may constitute a signal). A human
assessor reviews line listings or individual CIOMS forms for a
given period.
Statistical methods to identify drug-event pairs (or frequent
combinations of a drug and an event) that occur with disproportionately
high frequency in large spontaneous report databases.
Typical methodologies used include the Proportional Reporting Ratio
(PRR) or the Empirical Bayesian Geometric Mean (EBGM).
Qualitative method
Quantitative method
Sources:
https://www.ashfieldhealthcare.com/en/post/role-data-mining-signal-detection/
http://www.pipaonline.org/write/MediaManager/Members Area/Pharmacovigilance/Signal
Detection/PIPA_UK_Guidelines_Signal_Management_May_2012.pdf
Find out more about Signal Detection & Management Strategies at our training:
https://fleming.events/en/events/pharma/signal-detection-strategies-training