We are happy to announce that the article “Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model” was published on Clinical Pharmacology & Therapeutics Journal.
The publication derives from the activities carried out by the Working Group 3 ‘Data Sources and Multi-source Studies’ of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) in which the Working Group (WG) Health Data of the TEDDY Network is involved. Among the authors, there are Miriam C. J. Sturkenboom (Julius Global Health, Utrecht Medical Center University, The Netherlands) and Annalisa Landi (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Italy;) who are part of the Health Data WG while the whole group has been acknowledged for the useful comments provided.
The article describes the relevant role of the of post-marketing safety studies, in particular of the multi-databases studies (MDS), studies conducted in population-based databases and using at least two healthcare databases, which are not linked with each other at an individual person level, with analyses carried out in parallel across each database applying a common study protocol. The authors identified four strategies to execute MDSs, classified according to specific choices in the execution: a) local analyses; b) sharing of raw data; c) use of a common data model with study-specific data; d) use of general common data model.
The article is available at this link.