The European Medicines Agency (EMA) has published a report highlighting the outcomes of the workshop on access to clinical trial data and transparency recently hosted at the Agency on November 22.
The report summarises the key interventions of the six panellists and other speakers, and outlines the next steps proposed by the Agency with regard to proactive publication of clinical trial data once the marketing authorisation process has ended.
As follow-up to the workshop, the EMA will establish policies in close dialogue with its stakeholders in five different areas identified during the workshop. These are protecting patient confidentiality, clinical-trial data formats, rules of engagement, and good analysis practice and legal aspects.
The EMA is forming advisory groups with broad representation from all parties, which will start working on these topics in early 2013.
More details on these advisory groups and information on expressing interest to join one or more can be found at the following link:
EP News Bureau – Mumbai
