Observational Medical Outcomes Partnership (OMOP)

The Observational Medical Outcomes Partnership (OMOP) was a public-private partnership involving the FDA, multiple pharmaceutical companies, and healthcare providers established to inform the appropriate use of observational healthcare databases for studying the effects (risks and benefits) of medical products. Over the course of the 5-year project and through its community of researchers from industry, government, and academia, OMOP successfully achieved its aims to: 1) conduct methodological research to empirically evaluate the performance of various analytical methods on their ability to identify true associations and avoid false findings, 2) develop tools and capabilities for transforming, characterizing, and analyzing disparate data sources across the health care delivery spectrum, and 3) establish a shared resource so that the broader research community can collaboratively advance the science. OMOP demonstrated the feasibility of establishing a common informatics and research infrastructure to accommodate observational data of different types (both claims and electronic health records) from sources around the world, and successfully developed and executed large-scale statistical analyses capable of enabling active drug safety surveillance across prescription medications.  OMOP was successfully transitioned to the Reagan-Udall Foundation in 2013.