On 21 Jan 2015, the EMA launched a public consultation on how the transparency rules of the new Clinical Trials Regulation will be applied in the new EU clinical trial database. The Clinical Trials Regulation transforms the amount of information that is publicly available for each clinical trial conducted in the EU by requiring transparency on the authorisation, conduct and results of trials.
The new EU portal and EU database will provide the system that will be used to submit and maintain clinical trial applications and authorisations in the EU and will serve as the source of public information on the clinical trial applications assessed, and all clinical trials conducted in the EU.
While the EMA is responsible for the development and maintenance of the EU portal and EU database, it is the EU Member States that are responsible for authorisation and oversights of clinical trials in the EU. The public will be able to access detailed information about each trial with a summary of the results and a lay summary being published 12 months after the end of the trial. For trials included in a marketing authorisation application in the EU, clinical study reports will be published 30 days after the procedure for granting the marketing authorisation has been completed or the application has been withdrawn.
The document under consultation sets out proposals for the application of the transparency rules of the European Clinical Trial Regulation for stakeholders to review and comment on. Comments are invited before 18 Feb 2015. The European Clinical Trial Regulation is distinct from the EMA’s policy on the publication of clinical trial data, which came into force in Jan 2015. Under the EMA’s policy, the EMA proactively publishes the clinical study reports submitted as part of marketing authorisation applications for human medicines. This means that the policy applies to clinical reports of studies that are beyond the scope of the European Clinical Trial Regulation as it, for example, also includes clinical trials that are conducted outside the EU but submitted to the EMA for marketing authorisation in the EU.