Safety surveillance and the estimation of risk in select populations: Flexible methods to control for confounding while targeting marginal comparisons via standardization

We consider the critical problem of pharmacosurveillance for adverse events once a drug or medical product is incorporated into routine clinical care. When making inference on comparative safety using large‐scale electronic health records, we often encounter an extremely rare binary adverse outcome with a large number of potential confounders. In this context, it is challenging to offer flexible methods to adjust for high‐dimensional...