• 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.