The European Medicines Agency (EMA) has launched a new version of the European Clinical Trials Database (EudraCT). This version, EudraCT V9, marks the initial step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR).
EudraCT is a database used by national competent authorities to enter protocol-related information on clinical trials submitted by clinical trial sponsors, but also includes protocol-related information on clinical trials in third countries if they are included in a PIP. The database is hosted by the EMA.
Users are able to view the description of phase II to phase IV adult clinical trials where the investigator sites are in the EEA, as well as any clinical trials in children with investigator sites in the EU and any trials that form part of a PIP, including those where the investigator sites are outside the EU.
EudraCT already contains protocol-related information submitted by sponsors for interventional clinical trials conducted in European economic area countries and/or in third countries, when the clinical trial is part of an agreed Pediatric Investigation Plan (PIP). Clinical-trial sponsors are encouraged to register on the EudraCT website to start uploading summary results. Results posted by sponsors in EudraCT will start to become publicly available once the EMA has launched the complementary new version of the EU CTR towards the end of 2013.
The initial release of EudraCT will be followed by further updates to the system in 2014, which will provide improved functionalities for sponsors and EU regulatory authorities. With the launch of further iterations by mid-2014, the modalities and timing of posting of result-related information as described in the EC guideline will apply, and sponsors will then be required to post result-related information.
The EMA supports international standardization of data requirements for clinical trial registration. EudraCT’s data requirements are already substantially aligned with those of ClinicalTrials.gov and the EMA works closely with the NIH.
The EMA will make the data descriptions and technical specifications available to enable stakeholders to build systems that can generate structured data sets and upload them electronically into EudraCT.