BLOG – Real World Data’s Expanding Role in Conducting Research & Lessons Learned from COVID-19

My team and I are very pleased to see the COVID-19 virus waning thanks to vaccines (and mutations), and that we’re now in a much better place. However, it’s nevertheless still with us and there’s necessarily great interest in the long-term consequences of long COVID, i.e., infection/re-infection, infection with different variants, infection with people vaccinated, boostered and all of these variations. It will therefore continue to be one of our key priority research areas, more specifically, on vaccine safety and effectiveness, especially in sub-populations that might have initially been under-represented or where we had very little data, e.g., in children or the elderly.

When it comes to long COVID, the first challenge we faced was of course identifying it for the first time with RWD (Real World Data) as it was a new condition with no code. It’s only recently that the WHO came up with a definition for long or persistent COVID based on symptoms combined with duration. Since then we can operationalise and identify this in RWD, but it takes a lot of effort to do this properly.

We’re now carrying out this work with two EHDEN Data Partners and will invite other Data Partners to collaborate with us in the coming months. It’s important to have data from different settings and regions so we can phenotype this condition, and then potentially characterise its descriptive epidemiology, i.e., who does it effect?, are there clusters of people who have different symptoms than others and why, etc?

Also of great importance to us is Post-Acute COVID-19 Syndrome and complications from COVID-19, such as blood clots, heart attacks, kidney failure, and potentially other conditions we are not yet even aware of. We need to better understand if this is still happening with vaccinated people, and if so, who is at high risk of these complications because some of them are preventable. There is definitely still much to learn in this space.

Faster and better…

While traditional research and use cases will always continue, I think it’s important to call out the strides that we’ve been making with Data Partners from the EHDEN federated network conducting studies via study-a-thons and evidence-a-thons (E-thons). Inspired by the IT/software development communities, we have had great success with these new formats that you could say are “research sprints” where we prepare as much as possible and then meet live or virtually for a few days or a week and finalise and deliver a piece of work, as we did, for example, with rheumatoid arthritis, knee replacement, prostate cancer, and COVID-19.

I’m certain that the number of study-a-thons and E-thons will gain momentum as Data Partners finish mapping their data to the OMOP common data model and can then move into the most important phase of conducting research on standardised data and generating real world evidence (RWE). This, in turn, will help transform all aspects of medicine development, influence decision-makers such as regulators and payers – and lead to a faster medication approval process.

The launch of EHDEN’s new Portal and Data Catalogue and its supporting dashboards and research tools will no doubt facilitate faster and better quality data sharing – and inspire Data Partners to initiate their own study-a-thons and E-thons. Anyone who would like access to the more than fifty publications (studies, use cases, study-a-thons and E-thons) so far carried out by EHDEN/OHDSI colleagues can find them all here.

COVID-19 has been and still is a formidable foe, but paradoxically is actually helping to catalyse and galvanise a large part of the population about the importance and value of RWE and data-sharing in terms of how we manage a pandemic. Seeing progress like this in real-time and the rapid growth of federated data networks like EHDEN is very gratifying and serves to keep scientists like me and my team inspired to keep this paradigm shift moving full steam ahead!

Dani Prieto-Alhambra

Professor of Pharmaco and Device Epidemiology, NDORMS, University of Oxford, UK

Professor of RWE, Erasmus Medical Center, Rotterdam, The Netherlands

EHDEN Research Coordinator