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Open Data

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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Données de santé : pourquoi l’opendata est une nécessité et comment y parvenir

Lundi 28 avril, s’achève la consultation publique sur l’ouverture des données publiques de santé lancée en novembre 2013 par le ministère des Affaires sociales. Un sujet sensible, car les données de santé touchent à l’intime de chaque citoyen, et imposent donc un respect de la vie privée, mais aussi parce qu’elles aiguisent l’appétit de nombreux acteurs. Trois experts des données de santé expliquent à quelles conditions l’ouverture des données de santé est envisageable, et proposent leur modèle. Pour lire l’article de la Gazette.fr

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EMA still not there yet on data-sharing

The European Medicines Agency (EMA) has once again extended its deadline for publishing a definitive policy on the disclosure of clinical-trial data for newly licensed medicines. The EMA is, nonetheless, moving towards the final stages of introducing a proactive disclosure policy, with particular emphasis on resolving the vexed issue of data in clinical study reports (CSRs) that trial sponsors say is commercially confidential. At the beginning of May, the agency will launch a “final round of targeted consultations” with key stakeholders on its draft policy for proactive publication of, and access to, clinical trial data following publication of the EMA’s …

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