#21 Unlocking the power of real-world data – Patrick Ryan

Drug Safety Matters

The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson & Johnson discusses how to harness real-world data for patient safety.
Tune in to find out:

• How real-world data is collected and analysed
• Which pharmacovigilance processes will benefit most from it
• How to make data accessible without infringing patient privacy

Want to know more?
Review the basics of real-world data and its use in the medicines life cycle in Pharmaceutical Medicine, or read up on the opportunities and challenges for pharmacovigilance in Clinical Pharmacology & Therapeutics.
In partnership with the Observational Health Data Sciences and Informatics (OHDSI) and the European Health Data & Evidence Network (EHDEN) consortia, UMC researchers are exploring how real-world data can help prioritise and validate signals in pharmacovigilance. Read about their latest collaboration on Uppsala Reports.
Another important player in the real-world data space is the Data Analysis and Real World Interrogation Network (DARWIN), which aims to provide timely and reliable evidence from real-world healthcare databases in the EU to improve the safety and effectiveness of medicines.
For more on real-world evidence and the challenges of working with big data, don’t miss the Voice of EHDEN podcast or this conversation with Elena Rocca from the Drug Safety Matters archive.

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

• The evidence for signals
• Assessing safety in clinical trials

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

Chapters

1. #21 Unlocking the power of real-world data – Patrick Ryan (00:00:00)

2. Intro (00:00:15)

3. Welcome, Patrick! (00:01:38)

4. What is real-world data? (00:01:46)

5. Sources of real-world data (00:04:15)

6. Value for pharmacovigilance (00:06:43)

7. Signal detection or assessment? (00:09:19)

8. Post-authorisation safety studies (00:11:31)

9. OHDSI and EHDEN (00:12:55)

10. Study-a-thon (00:15:31)

11. Challenges (00:19:23)

12. Data privacy (00:21:58)

13. Data quality (00:23:55)

14. Quantity vs quality (00:25:55)

15. Using real-world data more (00:28:51)

16. Outro (00:32:03)