The need to pool data across different databases in order to gain power and increase generalisability of the results is becoming increasingly necessary. In Europe, collaborations for multi-database studies have been strongly encouraged over the last years by the drug safety research funded by the European Commission (EC) and public-private partnerships such as the Innovative Medicines Initiative (IMI). The funding resulted in the conduct of groundwork necessary to overcome the hurdles of data sharing across countries. A growing number of studies use data from networks of databases, often from different countries.
In the US, the HMO Research Network (HMORN), the OHDSI and the Sentinel initiative are examples of consortia involving health maintenance organisations that have formal, recognised research capabilities. Networking implies collaboration between investigators in sharing expertise and resources. The ENCePP Database of Research Resources may facilitate such networking by providing an inventory of research centres and data sources that can collaborate on specific pharmacoepidemiology and pharmacovigilance studies in Europe. It allows the identification of centres and data sets by country, type of research and other relevant fields.
From a methodological point of view, research networks have many advantages:
Different models have been applied for combining data or results from multiple databases. A common characteristic of all models is the fact that data partners maintain physical and operational control over electronic data in their existing environment. Differences however exist on whether a common protocol or a common data model is applied across all databases to extract, analyse and combine the data. A common data model (CDM) approach provides a similar representation of the database that allows standardisation of administrative and clinical information and facilitates a combined analysis across several databases. The CDM can be systematically applied on all data of a database (generalised CDM) or on the subset of data needed for a specific study (study-specific CDM).
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|