Drug Safety Matters

#20 The evidence for signals – Daniele Sartori


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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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We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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