EMA begins final steps on clinical trial data transparency policy

The European Medicines Agency (EMA) has announced that it will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical-trial data at the beginning of May. This will give key stakeholders and the Agency the opportunity to address any outstanding issues before the final policy is presented to the EMA’s Management Board for endorsement in June 2014.

This consultation is meant to clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy. The targeted discussions will focus on the presentation by the EMA of the principles set for the possible redaction of the clinical study reports to be published. If applied, the redactions will be based on the criteria identified by the Agency for those parts ofclinical trial data that exceptionally contain commercially confidential information. They will also aim to clarify how the concerned data-owners (e.g. marketing authorisation holders) will be consulted before publication of their clinical study reports, and user-friendly technical measures to make the data accessible under the new policy including their terms of use.