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OHDSI Awarded $10M FDA Contract to Monitor Safety and Effectiveness of Vaccines, Biologics

Extensive supply chain and manufacturing challenges await any approved vaccine for COVID-19. Credit: Shutterstock, modified.

Researchers within the Observational Health Data Services and Informatics (OHDSI) community were recently awarded a $10 million contract from the U.S. Food and Drug Administration (FDA) to provide support to the Biologics Effectiveness and Safety (BEST) program, which was launched by the FDA Center for Biologics Evaluation and Research (CBER) in 2017.

The lead research team, primarily comprised of OHDSI personnel from Columbia University, UCLA, and Northeastern University, will provide support to the BEST system in its mission to conduct safety and effectiveness surveillance of biologic products (vaccines, blood and blood products, tissues and advanced therapeutics).

The effort will include serving in a convening role to develop methods related to using observational data from electronic health records and administrative claims to study the effectiveness and safety of biologics, work collaboratively with FDA staff to plan, develop, coordinate, host and convene meetings and workshops, and educate FDA staff and external stakeholders on the BEST infrastructure, capabilities, and applications that serve FDA and stakeholder needs.

“Sound approaches to monitor vaccine safety and effectiveness across large populations have their limitations; this is particularly important with the upcoming roll-out of COVID-19 vaccination programs, and we stand ready to help,” said Marc Suchard, Professor of Biostatistics at UCLA, who will lead methods development under this contract.

With collaborators from more than 30 nations around the world and over one billion patient records across 130 databases mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model, the OHDSI community has both developed open-source tools to produce reliable, reproducible real-world evidence and published studies that have impacted both methodological research (LEGEND principles, ENCePP guidelines) and clinical decision-making (Lancet antihypertensive study, hydroxychloroquine safety profile).

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