EMA Unveils Plans to Consult Further on Data Sharing

Apr 10, 2014

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

The extra consultations are designed to clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy. They 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 EMA for those parts of clinical trial data that “exceptionally contain commercially confidential information,” according to a statement from the agency. The discussions will also aim to clarify how the concerned data-owners (e.g. marketing authorization holders) will be consulted before publication of their clinical study reports, and user-friendly technical measures will seek to make the data accessible under the new policy, including their terms of use.

EMA will liaise shortly with organizations representing patients, academia, pharmaceutical industry, as well as European Union institutions. It says it is committed to pursuing the objective of full transparency regarding clinical trial data because it believes that the release of data contributes to establishing trust and confidence in the system. The clinical trial data policy runs in parallel to other initiatives in the EU to increase transparency of clinical trials, most notably the new Clinical Trials Regulation, which received a strong vote in favor in the European Parliament on April 2, 2014. This piece of legislation is expected to come into force in mid-2016.

Read the full release here.

Download the brochure for the June 9-10th Publication and Clinical Trial Disclosure Event, taking place in Dublin this year