#23 Assessing safety in clinical trials – Marianne Lunzer & Sanja Prpić

Medicines safety monitoring is a continuous process that begins
with pre-marketing clinical trials and continues with
post-marketing studies to fill any gaps in knowledge. With
Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review
the pros and cons of various study types and the importance of
testing medicines on diverse populations.

Tune in to find out:


How pre- and post-approval safety studies are connected

Why safety assessors can request studies in underrepresented
populations

How new regulations are impacting safety assessments in the
EU



Want to know more?
This review in Trials summarises the methodological
challenges of assessing drug safety in clinical trials, while
this study in Clinical and Translational Science reviews how sex,
racial, and ethnic diversity in clinical trials have changed in
recent years.

Post-authorisation safety studies can be imposed or voluntary and
can be carried out as clinical trials or as non-interventional
studies. Read about the differences on the European Medicines
Agency’s website.

Large simple trials can control for biases in observational
research while still providing results that are generalisable to
real-world use. This review in Drug Safety explains why.

The new Clinical Trials Regulation harmonises how EU trials are
assessed and supervised for increased safety and transparency. As
part of these efforts, the SAFE CT project aims to facilitate
clinical trial coordination and safety assessments in the
EU.

For more on clinical trials, revisit this conversation with Peter
Doshi on restoring invisible and abandoned trials.


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


The evidence for signals

Unlocking the power of real-world data






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