Mini-Sentinel: Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database

This report presents different postmarket surveillance methods applicable to the distributed data setting with rare outcomes. The workgroup 1) reviewed the statistical and epidemiology literature on methods for survival outcomes that incorporate adjustment for confounders using a causal inference approach; 2) assessed the methods’ applicability to Mini-Sentinel and made recommendations on which strategies were best suited for use within this setting, where rare events, a distributed data environment, and sequential testing introduce new complications; and 3) evaluated, via simulation, the most promising existing approaches and new approaches tailored to the Mini-Sentinel setting.