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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article3 March 2022European Medicines Agency

Overview of the EU PAS Register post-authorisation studies performed in Europe between September 2010 and December 2018

An article written by ENCePP WG3 has been published with an overview of 1426 studies registered in the EU PAS Register from inception to December 2018. The analysis shows, that among the 1380 studies with adequate information, 65.4% were requested by a regulator, 82% were funded by a pharmaceutical company and 58.1% had a protocol published. 86% of the studies have an observational design, 2.1% of them are clinical trials and 26% of the 1227 observational studies are multi-database studies.

The authors provide suggestions on how to improve the register, e.g. by standardisation of data elements and provision of completion guidelines, which will be taken into account for the enhancement of the EU PAS Register that will be initiated later this year.  

 

Related information: Article | ENCePP WG3

Details

Publication date
3 March 2022
Author
European Medicines Agency