(P-337) E-CORE - Setting up a European Network for Real World COVID-19 Studies

Background: COVID-19 is an emerging and rapidly evolving infectious disease that has reached pandemic status. In June 2020, EMA funded the building of a framework for the conduct of multicentre cohort studies on the use, effectiveness and safety of medicines in COVID-19 patients..
The Evidence for COVID-19 Observational Research Europe Network (E-CORE) will leverage the resources already created by the OHDSI community and will aim to accelerate the generation of robust real-world evidence about the utilisation, effectiveness and safety of therapies for COVID-19 treatment. It is now open to both public and private funded studies.

Objectives: To describe the structure and governance of the E-CORE network, how data sources can join and the process of conducting a study in E-CORE.

Methods: This is a federated network with data sources mapped to the OMOP common data model (CDM) to enable common analytics. Any international data asset can participate in the E-CORE, provided they meet the quality criteria as minimum entry conditions and are willing to map their database to the OMOP-CDM. After engaging, CDM mapping and quality control, a feasibility test is run to see if the databases contain sufficient COVID-19 patient numbers as well as the desired variables for a specific study.

Results: The structure of the network includes project and scientific management, study design and execution, engaging new partners and communication. A local administrative centre is the main contact point for study funders and the study coordinating centre can differ between studies and is rotating between participants. To date, the Scientific Advisory Board is currently comprised of six members from academic and commercial institutions, all with experience in epidemiology, real world data, statistics, medicine and in multi-database studies.
Currently, data partners are represented by eleven databases from eight countries (DA Germany and a German hospital database, LPD Belgium, LDP and SNDS France, LDP Italy, IMRD UK, SIDIAP and HM Hospitales from Spain and IPCI Netherlands and Clinerion Serbia), seven of which are primary care, three hospital based and one claims database. The number of COVID-19 patients in these databases ranges from n=3,308 to n=124,221 between December 2019 and June 2020.

Conclusions: The E-CORE network provides a viable international infrastructure that can provide researchers with clinical cohorts of COVID-19 patients in order to accelerate the generation of evidence about the utilisation, effectiveness and safety of medicines for COVID-19 patients.