Regulatory Open Forum

Hey there, I'm Joanne Eglovitch, News Editor for Regulatory Focus, the RAPS news team.

I chatted with Peter Arlett, head of the European Medicine Agency's data analytics and methods task force, for an interview at DIA Europe last month. He told me about how a common data structure has been a "major enabler" of the EU's DARWIN network, allowing real-world evidence studies to be conducted rapidly.

We also spoke about how RWE has evolved in recent years and its use as a tool to support marketing authorization applications.

I encourage you to read the full interview here!

Thank you very much for the post. The article is very helpful and I would like to learn more. I have a few questions:

1. There is such an organization in the EU but not in the US--could it be because the US has all commercial RWD, but in the EU, there is no commercial RWD because of GDPR?
2. They use a standard data model, the OMOP common data model, to compare patients using different datasets. That is great. Are people in the US using the same data model so that we can compare patients' outcomes across different regions/countries?

Thank you!
Yuwei

Hi Yuwei, thank you for your interest. The US does not have a similar data collection system as DARWIN, maybe this relates to GDPR. The agency does collect RWD under its Sentinel postmarket surveillance program. FDA allows sponsors to collect RWE based on the 21st Century Cures Act to demonstrate drug safety and effectiveness, but does not collect the data itself. Duke University has a highly-regarded group that is collecting RWD at Duke University: https://healthpolicy.duke.edu/projects/real-world-evidence-collaborative

There is also a smattering of patient groups out there collecting RWD as well, and these may be geared to certain diseases.  

Regarding your second question, I'm not sure if these groups, such as Duke, use the OMOP common data model. Though it would certainly make sense to do so! 

These are good questions, and I can get back to you once I know more.

Regards,

Joanne

Joanne