Open Data

Hold-up sur les données de santé !

2013 fut marqué par la bataille des industriels de santé pour l’ouverture des données de santé. 2014 s’est achevé sur le combat des professionnels de santé pour une ouverture respectueuse du secret médical. 2015 pourrait rester dans les annales comme l’année du hold-up sur les données de santé ! Pour lire l’article de Pierre Desmarais

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Johnson & Johnson Will Make Clinical Data Available to Outside Researchers

The health care giant Johnson & Johnson has agreed to make detailed clinical trial data on its medical devices and diagnostic tests available to outside researchers through a collaboration with Yale University, making it the first large device manufacturer to systematically make such data public. The announcement came on the same day that the Institute of Medicine, of the National Academy of Sciences, called on all sponsors of clinical trials to share detailed study data with outside researchers and recommended that such data be made available within 30 days of a product’s approval. The dual developments are part of a …

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The Lancet | EMA’s transparency seems to be opaque

The European Medicines Agency (EMA) has now adopted its policy about access to clinical trial data,1 more than a year after the release of the first draft for public consultation. Although intended to boost accountability and trust in medical research, the policy does not seem to meet such expectations. The main concern is with respect to which data and documents can be accessed. The policy applies only to dossiers submitted through the centralised procedures from 2015. Pharmacovigilance data are not deemed in the policy. Before publication, the holder of marketing authorisation could edit clinical overviews, study summaries, and reports to …

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