The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency. Multi-database studies (MDS) leveraging secondary data have become an important strategy to conduct post-authorization studies (PAS) in recent years. The “Overview of the European post-authorisation study registerpost-authorization studies performed in Europe fromSeptember 2010 to December 2018”, provides a detailed description of all studies registered in the European post-authorisation study (EU PAS) register from its inception till the end of 2018, focusing on various aspects of study design and MSD specifically.
Authors found that observational studies were the most common type of studies in the EU PAS register. One quarter of observational studies were MDS which hold untapped potential to investigate special populations, such as patients with rare diseases and paediatric patients.
However, orphan drugs were not commonly investigated using MDS, although such studies may have a lot of potential in the rare disease field given the small population sizes expected and the increasing need of merging data from different sources to speed up the development of these medicines.
Importantly this study is the only one that validates the inter-rater reliability of different collaborating centres during the data collection process. This analysis suggested that information recorded in the EUPAS register is often not clear or complete, thus, increasing the quality of study-related information would considerably increase the transparency of research.
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