EMA announces final steps for its clinical trial data policy
Will have discussions with key stakeholders in May
The European Medicines Agency (EMA) will launch final targeted consultations with key stakeholders on its draft policy on the publication of and access to clinical trial data at the beginning of next month. 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.
The consultation aims to clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy.
The discussions will focus on the EMA's presentation 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 of clinical trial data that exceptionally contain commercially confidential information.
The discussions also aim to clarify how 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.
The Agency will liaise shortly with organisations representing patients, academia, pharmaceutical industry, as well as European Union (EU) institutions.
The EMA says it is committed to pursuing full transparency of clinical trial data because 'its release 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 favour in the European Parliament on 2 April. This legislation is expected to come into force in mid-2016.