The article “Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018” has been recently published in the Pharmacoepidemiology & Drug Safety journal.
The study provides a detailed description of all studies registered in the EU PAS Register from its inception till the end of 2018, focusing on various aspects of the study and multiple database studies specifically.
Data related to transparency, regulatory obligations, scope, study type, study design, type of data collection and target population was collected, by using publicly available information in the EU PAS register and a standardised data collection form.
Data extraction and validation process were carried out independently by 14 centres, belonging to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Fedele Bonifazi, Annalisa Landi, Maddalena Toma and Antonella Didio, researchers from Fondazione Gianni Benzi actively participated in both the collection and revision stage of this work.
Results show that observational studies are the most common type of studies in the EU PAS register, but 30% used primary data, which is more resource intensive. Moreover, almost half of observational studies using secondary data were multiple database studies.
You can find the full article here!