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Vaccine Surveillance Efforts Highlighted
In Recent OHDSI Community Call
Vaccine surveillance is a subject of global interest currently, and the OHDSI community has joined the conversation through its work with the FDA BEST program.
The March 23 OHDSI Community Call featured a presentation on the community’s work with the FDA BEST program to support its mission to conduct safety and effectiveness surveillance of biologic products (vaccines, blood and blood products, tissues and advanced therapeutics).
Discussion topics included:
• FDA BEST Overview; Research Methods Development – Incidence Rates for Vaccine Safety (George Hripcsak)
• FDA Workshops and Seminar Series (David Madigan)
Watch The Presentation Here
• Research Methods Development – Small Sample Meta-Analysis (Marc Suchard)
• Training and Engagement (Rita Kukafka)
See the March 23 presentation slides here.
Researchers within the OHDSI community were awarded a $10 million contract last summer 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 is primarily comprised of OHDSI personnel from Columbia University, UCLA, Northeastern University and Johns Hopkins University.
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.
