The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) seeks to build capacity in the European Union to use multi-centre studies to monitor the benefit-risk profile of marketed drugs. In August 2012, an ENCePP working group launched a survey of researchers coordinating multi-database drug-safety projects that have been publicly funded by the European Commission with the aim of defining current practice in Europe in combining data from multiple sources. The semi-quantitative questionnaire consisted of 14 categorised questions relating to the databases that were being used and the approaches in practice taken by researchers working across multiple databases. It was circulated to the research coordinators involved in consortia funded under the Seventh Framework Programme Cooperation Specific Programme Health 2007 – 2013 and/or European Medicines Agency funded drug safety studies and/or the PROTECT project. Responses were received from 13 of the 14 researcher coordinators covering 16 of 18 projects. The number of databases used in individual projects ranged from 2 to 11 and 8 of the projects (44%) involved pooling data from different databases. The survey documents an active research arena in multi-database research in Europe as a result of public funding. It also has shown the heterogeneity of the methods used to combine data from multiple databases. The interpretation of this heterogeneity is, however, complex and it has yet to be established if a single model is the best approach. To this end, ENCePP is well-positioned to conduct further research and develop guidance.

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EncePP) survey of methodologies for European Union publicly funded multi-database safety studies

Carmen Ferrajolo;
2014

Abstract

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) seeks to build capacity in the European Union to use multi-centre studies to monitor the benefit-risk profile of marketed drugs. In August 2012, an ENCePP working group launched a survey of researchers coordinating multi-database drug-safety projects that have been publicly funded by the European Commission with the aim of defining current practice in Europe in combining data from multiple sources. The semi-quantitative questionnaire consisted of 14 categorised questions relating to the databases that were being used and the approaches in practice taken by researchers working across multiple databases. It was circulated to the research coordinators involved in consortia funded under the Seventh Framework Programme Cooperation Specific Programme Health 2007 – 2013 and/or European Medicines Agency funded drug safety studies and/or the PROTECT project. Responses were received from 13 of the 14 researcher coordinators covering 16 of 18 projects. The number of databases used in individual projects ranged from 2 to 11 and 8 of the projects (44%) involved pooling data from different databases. The survey documents an active research arena in multi-database research in Europe as a result of public funding. It also has shown the heterogeneity of the methods used to combine data from multiple databases. The interpretation of this heterogeneity is, however, complex and it has yet to be established if a single model is the best approach. To this end, ENCePP is well-positioned to conduct further research and develop guidance.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11591/387233
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