New approaches to fill the methods gap in pharmacovigilance

Let’s have a closer lookstudy design issues that could have been tackled Exposure misclassification Whole follow-up period was looked at: continuous users vsswitchers vs non-use Exposure measured during a 4 -6 month run-in period Solution: time-varying exposue measument Selection bias Incident users mixed with prevalent users, while hazardchange over time Proportion of prevalent users differs per drug and per study Type 1 and type 2 diabetes, different proportions Solution: subgroup analyses Different comparator groups Human insulin Insulin other that glargine27