OHDSI Awarded $10 Million FDA Contract to Support Safety/Effectiveness Surveillance of Vaccines, Other Biological Products

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).

Specific means of FDA support through this grant will include serving in a convening role to 1) develop methods related to using observational data from electronic health records and administrative claims to study the effectiveness and safety of biologics, 2) work collaboratively with FDA staff to plan, develop, coordinate, host and convene meetings and workshops, and 3) educate FDA staff and external stakeholders on the BEST infrastructure, capabilities, and applications that serve FDA and stakeholder needs.

OHDSI is a global, multi-stakeholder, interdisciplinary collaborative which aims to bring out the value of health data through large-scale analytics and an open-science approach in order to generate the evidence that promotes better health decisions and better care. The Columbia University Department of Biomedical Informatics serves as the coordinating center.

“We are very excited to partner with the FDA to address surveillance of biologics, including vaccine safety, as it brings the knowledge, experience, and tools of OHDSI to bear on problems critically important to the nation,” said PI George Hripcsak, Chair and Vivian Beaumont Allen Professor of Biomedical Informatics at Columbia.

“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.

“Northeastern is delighted to partner with Columbia and UCLA to support the FDA in this crucial endeavor,” said David Madigan, Provost and Senior Vice President for Academic Affairs at Northeastern. “OHDSI supports a global community of researchers focused on generating reliable healthcare evidence. This project will greatly accelerate this work.”

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).