OBJECTIVES:

The EU PAS Register is a publicly available register of non-interventional post-authorisation studies. Main categories of scope include disease epidemiology, risk assessment, drug utilization study, and effectiveness evaluation. Here we aim to characterize DUS in terms of study design and types of variables collected.

METHODS:

We searched the ENCEPP website on 05-Jan-18 using following search terms: finalized, observational study, adults, drug utilization studies.

RESULTS: CONCLUSIONS:

In the PAS register, we observed a trend in increasing numbers of observational studies, including DUS. Most DUS include “risk assessment” as additional scope and therefore cover safety endpoints in addition to drug usage. The majority of DUS are retrospective cohort studies using existing database, but approximately a third are prospective observational studies.