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ARITMO in The Lancet

The Lancet
ARITMO has published a letter in The Lancet in response to a letter by Michael Galsworthy and colleagues (September 2012).

Michael Galsworthy and colleagues1 examine the academic output of investment in health research by European Union (EU) Framework Programmes (FPs) 5 and 6. Notwithstanding the limitations of their approach (such as the fact that only half of FP6 projects had unique alphanumeric codes), their statement that €570·2 million resulted in no detectable academic output omits other key dissemination areas.

We support Galsworthy and colleagues' suggestions that the EU should request annotated databases to be submitted to a central repository. However, the creation of such a repository requires an infrastructure that meets the different standards, data harmonisation, informed consent, and binding agreements from member custodians. The release of project data is already supported by key UK funders including the Medical Research Council2 and the Wellcome Trust.3 Other networks are also developing models of sharing: the European Network of Centres for Pharmacoepidemiology and Pharma-covigilance, coordinated by the European Medicines Agency (EMA), is promoting sharing of databases for use in pharmacoepidemiological studies to improve patients' safety.4

Data from projects concerning drug safety and pharmacovigilance must be closely analysed and assessed before publication, since they could entail regulatory actions by the EMA. From our own experience, the FP7 ARITMO project “Arrhythmogenic potential of drugs”, in response to an EMA call, has included scientific advice provided to the EMA Pharmacovigilance Risk Assessment Committee, assisting with evidence synthesis on drug safety from a European pharmacoepidemiological perspective, and enabling direct clinical translational benefits. Therefore key outputs from ARITMO and related drug safety projects should also be measured in terms of their effect on EMA regulatory decisions and policy, which cannot be measured by PubMed and Google Scholar.

Mariam Molokhia a, Fabrizio De Ponti b, Elijah R Behr c, Gianluca Trifirò d e, Miriam Sturkenboom d, on behalf of the ARITMO consortium

a Department of Primary Care and Public Health Sciences, King's College London, London SE1 3QD, UK
b Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
c Cardiovascular Sciences Research Centre, St George's University of London, London, UK
d Department of Medical Informatics, Erasmus University Medical Centre, Rotterdam, Netherlands
e Department of Clinical and Experimental Medicine, Section of Pharmacology, University of Messina, Messina, Italy