The European Medicines Agency (EMA) has launched an updated version of its European Clinical Trials Database (EudraCT), a move that brings the agency closer to its goal of publicly releasing clinical trial results through the European Union Clinical Trials Register (EU CTR).
The EMA is encouraging clinical trial sponsors to register on the EudraCT and begin uploading summary results. These results will be available to the public once the EMA has launched its complementary new version of the EU CTR towards the end of 2013.
Mandatory posting of summary results in accordance with a European Commission guideline published last year will take effect around the middle of 2014, once the EMA has further updated its system to improve functionality for both trial sponsors and EU regulatory authorities.
“With the launch of these further iterations of EudraCT 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 agency states.
The Commission’s guideline, Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006), was published in the Official Journal of the European Union in October 2012.
Next year, the EMA will introduce a tiered system of access to clinical study reports and raw trial data but the system would not apply retroactively. EMA executives said the system would be introduced once the agency has published its European Public Assessment Report on an application for centralised marketing authorisation.Also not part of the new tiered system are parliamentary amendments to proposed clinical trial regulations that would require sponsors to publish full clinical study reports once a marketing-authorisation decision had been taken.
The EMA said the launch of 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.” EudraCT already contains protocol-related information submitted by sponsors for interventional clinical trials conducted in European Economic Area countries, and/or for those conducted in third countries where the trial is part of an agreed Paediatric Investigation Plan, the agency notes.The EU Clinical Trials Register originally was scheduled to be launched at the end of 2009. It eventually made its debut in March 2011.
At the time, the EMA explained that including summaries of trial results on EudraCT needed to wait until Version 9.0 of the database was drafted. Publication of results summaries on the EU Register of Clinical Trials would “require a major upgrade to the existing system, the start of which will depend on finalisation of the [draft] guideline and availability of budget and resources”, the EMA said in March 2011.
Summaries of clinical trial results have been a feature of ClinicalTrials.gov, the public online registry run by the U.S. National Institutes of Health, since October 2008.
Announcing the EudraCT V9 upgrade, the EMA said it “supports international standardisation of data requirements for clinical trial registration” and that EudraCT’s data requirements are “already substantially aligned with those of ClinicalTrials.gov”.