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Active Presecription Drug Safety Surveillance: Exploring Omop 2011-2012 Experiments, Susan Gruber, James M. Robins

Susan Gruber

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 …