Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018.

ABSTRACT:

Background

The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested PAS, commonly observational studies, must be recorded in this register. Multi-database studies (MDS) leveraging secondary data have become an important strategy to conduct PAS in recent years, as reflected by the type of studies registered in the EU PAS register.

Objectives

To analyse and describe PAS in the EU PAS register, with focus on MDS.

Methods

Studies in the EU PAS register from inception to 31st December 2018 were described concerning transparency, regulatory obligations, scope, study type (e.g., observational study, clinical trial, survey, systematic review/meta-analysis), study design, type of data col

SUBMITTER: Sultana J 

PROVIDER: S-EPMC9303697 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature