Tuesday, 4 December 2012

Publishing clinical-trial data

On the 22nd of November a workshop on access to clinical-trial data and transparency was held by the European Medicines Agency. The EMA decided this year to encourage publication of clinical-trial data in order to allow for more re-analysis thereof by stakeholders. However, since this could lead to some practical issues (e.g., regarding patients' data confidentiality) consultations with stakeholders are needed before a specific policy will be established. During the workshop advisory groups were established (participation in them is still open) that would analyse and present their findings by the end of April 2013 on the following issues: protection of patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice, legal  aspects. The pro-active publication of clinical-trial data is expected to come into force on 1 January 2014.

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