European Union grant ALERT project for the early detection of adverse drugs events

Barcelona 01 April 2008A new European Union-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).

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Before launching a new drug to the market, it is tested on thousands of people, but adverse reactions (side effects) may not be detected until many more patients have used the drug. Once the drug is on the market, clinicians are responsible for recognizing and reporting suspected side effects, which are collected in so-called spontaneous reporting systems. However, a number of recent, highly publicized drug safety issues showed that adverse effects of drugs may be detected too late, when millions of patients have already been exposed.

With the aim of improving this system, ALERT will analyse data from electronic health care records (EHRs) of over 30 million patients from The Netherlands, Denmark, the United Kingdom, 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. Also from a commercial and regulatory perspective the cost of a false-positive signal is significant.

To discriminate between true signals and spurious signals, in ALERT a possible biological explanation is sought for each signal. This process of signal substantiation requires that the signal be placed in the context of our current understanding of possible biological mechanisms. ALERT will use to the maximum the currently available databases that contain information about these biological mechanisms and augment that understanding with in silico models and simulations of the behaviour of drug and biological systems. ALERT will also rely on experimental screening to test the causal hypothesis generated during the substantiation of signals.

The project partners emphasize 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."

In the United Kingdom, academics will use a research database of about 10 million patients from the not-for-profit QResearch, a partnership between the University of Nottingham and Egton Medical Information Systems. Other institutions involved in the project that will analyse their own respective databases include:

  • The Arhus University Hospital in Denmark;
  • Erasmus University Medical Center in The Netherlands; and
  • The University of Santiago de Compostela in Spain.

"The ALERT project aims to develop the first Europe-wide computerized system to detect adverse drug reactions better and faster than the current spontaneous reporting systems", Julia Hippisley-Cox, professor at the University of Nottingham and QResearch project leader, stated, adding: "Although we are not sharing data, we are sharing technology."

A total of 18 project partners from eight countries are involved in the ALERT project, which is co-ordinated by the Erasmus University Medical Centre Rotterdam, The Netherlands. The project cost amounts to nearly 5,9 million euro, 4,5 million euro of which are covered by the Europan Union's Seventh Framework Programme (FP7). The ALERT project started on 1 February 2008, with a total duration of 42 months.


Leslie Versweyveld

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