The Eu-Adr Alliance

The EU-ADR Alliance has been created to join a stable collaboration framework for running drug safety studies in a federated manner, especially when the participation of several EHR databases is required. In the EU-ADR Final Report the aim of this new project is well defined: “The EU-ADR Alliance would have the goal of running studies and answering drug safety questions from Members and external organizations in a collaborative and federated manner, generally in those cases where the participation of more than one database would be required. The Alliance will also be devoted to maintenance and continuing improvement of the EU-ADR system. Despite the focus on drug safety studies, it is envisaged that other potential studies can be tackled by means of the Alliance, such as support to policy making (i.e. generating indicators that can then be used by policymakers in their regulatory work).The EU-ADR Alliance is composed by members bringing in relevant expertise (EHR databases, information technologies, epidemiological expertise, project management, etc.). The EU-ADR Alliance is solidly grounded on the principles of federated databases, enabling collaboration among its members, research independence and scientific relevance. It undertakes commissioned studies or activities agreed by its members under an annual Alliance Research Plan. The advantage of running studies through the Alliance is that more powerful and faster studies can be set up and ran, given that a governance structure and working methods are already in place.” A proof-of-concept phase is ongoing, and three tenders have been awarded by the European Medicines Agency (EMA), which will test the EU-ADR Alliance concept and operations. These EMA studies are centered on the use of oral contraceptives, the risk of cardiac valve disorders associated with the use of biphosphonates, and the monitoring of the effectiveness of risk minimization in patients treated with pioglitazone-containing products. In addition, a number of drug safety projects funded by the Health Unit of the European Commission are currently under development based on some of the fundamental building blocks of EU-ADR. For instance, the EU-ADR Jerboa software is used for the extraction and pooling of individual patient’s data in all of these projects, thus proving the use of specific results beyond EU-ADR. The mentioned projects are SOS, ARITMO, SAFEGUARD and VAESCO, the later being funded by the European Centre of Disease Prevention and Control (ECDC).