This article describes elements that contribute to the success of electronic safety monitoring systems. Specifically, the authors examine the characteristics of a single drug-outcome pair, for which two large collaborative groups have come to results that have many points in common. Using examples, their goal is to suggest features of a disease problem and data systems that may lead to repeatable findings.
The article focuses in particular on the association between angiotensin-converting enzyme (ACE) inhibitors and angioedema. The two analytic groups considered are the FDA’s Mini-Sentinel distributed data network and the Observational Medical Outcomes Partnership (OMOP).