A new EU-funded information and communication technology (ICT) project is tackling issues of safety in newly developed drugs. Over the next three and a half years, the ALERT (‘Early detection of adverse drug events by integrative mining of clinical records and biomedical knowledge’) project partners will work on an innovative computer system for a better and faster detection of adverse drug reactions (ADRs).

Currently, so-called spontaneous reporting systems are used when side effects are discovered in a drug that is already on the market. Clinicians are responsible for recognising and reporting those side effects. “A number of recent, highly publicised drug safety issues showed that adverse effects of drugs may be detected too late, when millions of patients have already been exposed,” the research consortium comments.

With the aim of improving this system, ALERT will analyse data from electronic healthcare records (EHRs) of over 30 million patients from the Netherlands, Denmark, UK, Spain and Italy, using a variety of computational techniques. Those techniques, including text mining and epidemiological computing, will help to retrieve information from the data and detect ‘signals’, such as combinations of drugs and suspected ADRs that require further investigation.

The focus of the ALERT project will be on side effects in children, as relatively little is known about them and children are particularly vulnerable. Moreover, the interdisciplinary research team will attempt to find a way to discriminate between signals that do indeed indicate an ADR and spurious signals, which might even result in withdrawal of a useful drug from the market. In order to make this distinction, the ALERT researchers will look for a biological explanation for each signal by comparing the side effect with up-to-date knowledge about biological mechanisms. The findings will then be further corroborated in computer simulations and models.

The project partners emphasise that this kind of analysis is a continuous process: “As more patient data become available and medical, biological and molecular knowledge expands, previous conclusions will need to be revisited. In order to deal with this constant process of revision, ALERT will focus on automated procedures as much as possible.”

A total of 18 project partners from eight countries are involved in the ALERT project, which is coordinated by the Erasmus University Medical Centre Rotterdam, Netherlands. The project cost amounts to nearly

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