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.
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