Introduction
PlasmodeSimulation is an R-package for creating simulated versions of healthcare databases—mapped to the OMOP Common Data Model—based on predefined cohorts. Unlike conventional approaches that fully generate synthetic patient-level data (demographics, diagnoses, medications, etc.), plasmode simulations reuse real patient records and focus on simulating only the outcomes. Specifically, after fitting outcome models to the observed data, the package generates new outcomes for every patient. Although still in early development, PlasmodeSimulation can already produce benchmark datasets with known positive and negative controls (i.e., treatment–outcome pairs with established effect sizes) to rigorously evaluate pharmacovigilance methods.
Installation
To install the latest version from github run:
remotes::install_github("inab-certh/PlasmodeSimulation")