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The ALERT Project

The ALERT Project. Early Detection of Adverse Drug Events by Integrative Mining of Clinical Records and Biomedical Knowledge. Johan van der Lei Erasmus MC – University Medical Center Rotterdam. Consortium Members. Participating institutions:

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The ALERT Project

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  1. The ALERT Project Early Detection of Adverse Drug Events by Integrative Mining of Clinical Records and Biomedical Knowledge Johan van der Lei Erasmus MC – University Medical Center Rotterdam

  2. Consortium Members • Participating institutions: • Aarhus University Hospital, Århus Sygehus, Denmark • Agenzia regionale di Sanità, Italy • AstraZeneca AB, Sweden • Erasmus University Medical Center, Netherlands • Fundació IMIM, Spain • Health Search - Italian College of General Practitioners, Italy • Imperial College London, UK • IRCCS Centro Neurolesi “Bonino-Pulejo”, Italy • London School of Hygiene & Tropical Medicine, UK • PHARMO Coöperation UA, Netherlands • Pedianet - Societa’ Servizi Telematici SRL, Italy • Tel-Aviv University, Israel • Università di Milano-Bicocca, Italy • Université Victor-Segalen Bordeaux II, France • University of Aveiro – IEETA, Portugal • University of Nottingham, UK • University of Santiago de Compostela, Spain • University Pompeu Fabra, Spain

  3. We need earlier detection of ADRs Clinical records as source International, diversity as asset Sheer volume (Alert: > 30.000.000 pts) Methods of signal detection “Real” challenge: detect false-positives Causal hypothesis Premises

  4. Fragmented universe Expertise is judged “locally” Each local environment has “own” rules If only …. Belief

  5. “We are not students of some subject matter, but students of problems. And problems may cut right across the borders of any subject matter or discipline.” K.R. Popper (1963). Conjectures and Refutations: The Growth of Scientific Knowledge.

  6. Multidisciplinary More than one discipline Separate contributions Interdisciplinary Integration and synthesis Exchange of methodology National Academy of Sciences, National Academy of Engineering, Institute of Medicine (2005). Facilitating Interdisciplinary Research. Multi versus Inter

  7. Consortium Members The ALERT Consortium is composed of: 15 beneficiaries + 3 subcontractors AZ AUH-AS UNOTT ICL EMC LSHTM PHARMO USC UB2 UNIMIB PEDIANET UAVR SIMG ARS FIMIM UPF NEUROLESI TAU (Tel–Aviv) EHRs Databases

  8. Spontaneous Reporting Systems Consortium Profile UB2 NEUROLESI EHRs Databases BMI Knowledge UNIMIB UPF PEDIANET USC AZ UNOTT EMC PHARMO ARS Extraction and Interpretation of Clinical Data TAU UAVR AUH-AS SIMG LSHTM ICL Project Management FIMIM

  9. “The time is upon us to recognize that the new frontier is the interface…. Innovators will need to jettison the security of familiar tools, ideas, and specialties as they forge new partnerships.” F.C. Kafatos, T. Eisner. Unification in the century of biology. Science, 2004;303:1257

  10. Can we detect events Can we relate these events to drugs Can we develop hypothesis that explain adverse events Can we detect adverse events earlier Can we avoid false positives Objectives

  11. Focus on science Focus on concrete questions Accept the lessons of Chaos Theory Questions will iterate The journey is the reward Respect local autonomy Foster respectful collaboration Respect and address ethical concerns Strategy

  12. Create companies or institutions Share data on the level of individuals Will not include `official` bodies Strategy – we will not:

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