EHDEN/OHDSI Feature in COVID-19 Real-World Evidence Primer

COVID-19 was declared a pandemic by the WHO in March of 2020 and EHDEN was formally launched in November 2018. With a solid foundation of Data Partners in place by early 2020, and since then, EHDEN has been collaborating with OHDSI (Observational Health Data Science and Informatics), our growing base of Data Partners, and other data sources to conduct research that generates real world evidence (RWE) to help the battle against COVID-19.

These research sessions have been run in so-called study-a-thons and evidence-a-thons whereby researchers meet, usually for one week, to share health data that have been standardised to the OMOP Common Data Model. Such evidence informed policy guidance by both the FDA and the European Medicines Agency (EMA),

Paradoxically, COVID-19 has made a positive contribution to how observational research is conducted – significantly speeding up the analysis time from what historically took years and months to now just weeks and even days. These ongoing efforts have resulted in a range of publications in major health journals, and for example, served to inform EMA in regulatory decisions on repurposing of therapies for treating COVID-19: The safety of hydroxychloroquine, alone and in combination with azithromycin.

The COVID-19 pandemic laid bare the limited interoperability capacity of the existing healthcare data infrastructure for assembling data to quickly address critical questions about a novel disease. Several initiatives have emerged to address this shortfall using RWD for COVID-19 observational research.

To learn from the evolving lessons of addressing the COVID-19 pandemic and to bolster the future use of real world data (RWD) and RWE, The FDA Foundation, in collaboration with the International Society for Pharmacoepidemiology (ISPE), created The COVID-19 Real-World Evidence Primer. The Primer consists of seven chapters that cover types of RWD, methods in RWE generation, examples of RWE studies and initiatives, and strategies for communicating about RWE.

OHDSI/EHDEN are showcased in Chapter 5: Multi-Stakeholder Initiatives – Defining the Future of COVID-19 Observational Research.

Commenting on this vital spirit of collaboration in the Primer, Dani Prieto-Alhambra, EHDEN’s  Research Coordinator, Professor of Pharmaco and Device Epidemiology, NDORMS, University of Oxford, and Professor Real World Evidence, Erasmus Medical Center, and contributor to OHDSI, “It’s a very inclusive community in which basically anyone is invited to come and join and work with us. You just join forums, attend one of the calls, and join a working group. It’s an open science community.”

“Congratulations to Reagan-Udall for spearheading such a comprehensive gathering of lessons learned addressing COVID-19. It clearly exemplifies the value and strides being made in working together and the need for rapid evidence generation facilitated by health data standardised to the OMOP Common Data Model. We are delighted to be included in the Primer,” added Nigel Hughes, Scientific Director, Epidemiology, Global R&D, Janssen, and EHDEN Co-Lead.


  1. Reagan—Udall Foundation for the FDA, Friends of Cancer Research; COVID-19 Real-World Evidence Primer, 2022 (online)