We asked Dr Miranda Davies, the DSRU’s Chief Medical Officer, to explain the key characteristics of European Network Studies:
Q.What are the DSRU’s European Network Studies?
A. European Network Studies are real-world studies conducted in several countries to a common protocol. The DSRU can be the leader or a participant in these studies. When the DSRU leads the study, we select partner organisations with suitable data sources in relevant countries.
In many cases, PRAC, the EMA’s pharmacovigilance committee, will require risk management or risk minimisation studies to be conducted in several European countries.
We can take the headache out of multi-country observational studies for the marketing authorisation holder.
Q.How do these studies work?
A. For European Network Studies, the DSRU writes a grand protocol that addresses the regulatory requirements or research question. Each partner organisation adapts the protocol to suit their setting and data source. Frequently the network studies use a common data model approach which brings together and harmonises data sources, ensuring that large European studies are conducted using a variety of data sources from different countries.
The co-ordinator of the study (the DSRU or another partner) manages the network, collates the data and writes all necessary study reports. We find that marketing authorisation holders appreciate that the network and the study is co-ordinated by another organisation, so that they don’t have to.
We have been collaborating on a range of pan-European safety studies which generate real-world evidence using a common data model approach.
Q. What are the benefits of European network studies?
A. The methodology suits a number of different types of real-world studies including post-authorisation safety studies (PASS) and studies to evaluate effectiveness of risk minimisation measures. The advantages of European Network Studies are the increased sample size and the involvement of healthcare systems in the different countries of the study partners.