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

Drug Safety Matters

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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About UMC
Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Chapter

1. #23 Assessing safety in clinical trials – Marianne Lunzer & Sanja Prpić (00:00:00)

2. Intro (00:00:15)

3. Welcome, Marianne and Sanja! (00:01:49)

4. How is safety studied in clinical trials? (00:02:04)

5. Strengths and limitations of clinical trials (00:04:22)

6. Connecting pre- and post-approval studies (00:07:17)

7. Large simple trials (00:09:13)

8. Strengths and limitations of post-authorisation safety studies (00:10:57)

9. Diversity in clinical trial populations (00:12:47)

10. International cooperation (00:17:10)

11. Clinical Trials Regulation (00:19:42)

12. Lessons from the COVID pandemic (00:22:49)

13. Integrating multiple sources of evidence (00:25:50)

14. Outro (00:29:44)