The EU-ADR alliance: A federated collaborative framework for drug safety studies

Abstract

Background: EU-ADR is a European research project resulting in a computerized system exploiting data from electronic healthcare records (EHR) for early detection of adverse drug reactions. The system identifies drug-event associations from epidemiological data and uses computational and text mining techniques to substantiate them in the light of current biomedical knowledge. EHRs of +30 million patients from several European countries are available. The EU-ADR system has been initially built for addressing relevant events for drug safety surveillance such as upper gastrointestinal bleeding, anaphylactic shock, acute renal failure, rhabdomyolysis, myocardial infarction, etc. Objectives: Based on the resulting system, the EU-ADR Alliance is devised as a collaboration framework for running studies and answering drug safety questions in a federated manner, using extracted data from multiple European private and public EHR databases. Methods: The EU-ADR Alliance will be composed by members bringing in relevant expertise (EHR databases, information technologies). It is based on the concept of federated databases, non-competition with its members, independence and scientific interest. It will undertake commissioned or members individual studies and the annual Alliance Research Plan. The advantage of running studies through the Alliance is that more powerful studies can be set up and run faster, given that a governance structure and working methods are in place. Results: EU-ADR Alliance candidate member organisations include eight European EHR database with access to +45 million patients from Italy, Netherlands, UK, Germany and Denmark. A proof of concept phase is ongoing. Studies contracted by the European Medicines Agency will utilise the EU-ADR Alliance concept and operations. These studies concern the patterns of use of oral contraceptives; exploring an association between cardiac valve disorders and the use of biphosphonates and the monitoring of the effectiveness of risk minimisation in patients treated with pioglitazone-containing products Conclusions: The EU-ADR Alliance will provide an unprededented framework to run drug safety studies across EHR databases with important power and speed benefits.