#20 The evidence for signals – Daniele Sartori

Spontaneous reports of adverse drug reactions are a common source
of evidence in pharmacovigilance, but as the science evolves, so
do the types of data used to find and assess signals. Uppsala
Monitoring Centre’s Daniele Sartori reviews how signal detection
practices have changed over time.

Tune in to find out: 


Which features of case reports are most often used to assess
causality 

Why pharmacovigilance experts should report clinical
assessments clearly 

How to shorten the time between signal detection and
communication 




Want to know more?

Check out the full scoping review that inspired this
episode.

In 2002, Meyboom and colleagues discussed criteria to select and
follow up on signals.

In the first chapter of Uncertainty in Pharmacology, Aronson
explains the difference between evidence for a mechanism and
evidence from a mechanism.

In 2018, Murad and colleagues published a method to evaluate the
quality of evidence in a series of case reports.

UMC scientists have shown how chemical information can support
timely signal detection.

This episode is the first of a three-part series on sources of
evidence in pharmacovigilance. Listen to the other two episodes
here:


Unlocking the power of real-world data

Assessing safety in clinical trials






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