The Observational Medical Outcomes Partnership (OMOP), a public-private research project aimed at evaluating and validating methods of using observational health care databases for active drug safety surveillance, is considering closer collaboration with FDA’s Mini Sentinel and the Patient-Centered Outcomes Research Institute.
The OMOP executive board proposes working with Mini Sentinel and PCORI in a tentative three-year plan posted recently on the project’s website for public comment.
The OMOP board proposes to “coordinate OMOP’s research with the research and practice of others in the fields of risk and effectiveness identification and interpretation.”
Mini Sentinel is a pilot project for FDA’s Sentinel Initiative, which is envisioned as a national post-market safety surveillance program drawing from a network of medical claims data and electronic health records.
PCORI was established by the Affordable Care Act to sponsor outcomes research, including comparative effectiveness research, for drugs and other medical treatments.
OMOP’s other proposed activities include developing a framework for incorporating observational data and stakeholder perspectives into decision making, as well as methods to enable active surveillance and risk identification for newly marketed medical products.