Skip to main content
Active presecription drug safety surveillance: Exploring OMOP 2011-2012 experiments
OMOP community meeting (2013)
  • Susan Gruber, Harvard School of Public Health
  • James M. Robins, Harvard School of Public Health

The Observational Medical Outcomes Partnership (OMOP), a consortium of pharmaceutical, FDA, and academic researchers focuses on developing and evaluating electronic records-based methods for enhancing post-market drug safety surveillance. The OMOP 2011-2012 experiment consists of applying variants of seven analysis methods to five different EMR or claims databases to estimate the increase (decrease) in risk associated with drug-outcome pairs whose causal association has been previously established, and serves as a gold standard for comparison. Variants of each method can produce very different effect estimates, sometimes at odds with the gold standard. We explore the reasons behind this heterogeneity, and in doing so increase our understanding of each method’s vulnerability to different sources of bias, limitations of the OMOP 2011-2012 experiment, and the challenges inherent in using observational data for post-market monitoring of drug safety.

  • OMOP,
  • OSIM2,
  • drug surveillance,
  • claims data
Publication Date
October 16, 2013
Citation Information
Susan Gruber and James M. Robins. "Active presecription drug safety surveillance: Exploring OMOP 2011-2012 experiments" OMOP community meeting (2013)
Available at: