1. The European Medicines Agency steps up the debate on open access to clinical trial data

    published on Friday, August 10, 2012 under Public Health

    The European Medicines Agency (EMA) has announced its plans to carry out a proactive publication of data related to clinical trials to allow interested parties full access to these data sets. However, before releasing this information it is necessary to address some political and practical issues. For that purpose the EMA is organising a workshop to be held on November 22.

    European regulators have raised the possibility of providing open access to data sets on the results of clinical trials. Some researchers have argued that such data should not be considered commercially confidential and that free access to them would represent a significant potential public health improvement. However, alongside this potential benefits, potential patient confidentiality violations should also be considered.

    Some recent studies about the potential of opening data sets on clinical trials show that opening this type of raw data sets to researchers would provide important benefits for public health. Computing and artificial intelligence techniques applied to rich-enough data sets would provide results in areas such as the appication of best treatment for each patient.

    To explore this matter, the European Medicines Agency (EMA) will organise a workshop on November 22 in order to collect different views from stakeholders regarding the access and use of these data sets. It aims at gathering a large number of institutions, research groups and interested citizens. Interested parties can register until October 31.

    The results of this meeting will inform the Agency to define the modalities of proactive access to clinical trials data sets, in a way that would be useful both for patients and public health in a context of openness and transparency.

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