The European Medicines Agency (EMA) has launched an updated version of its European Clinical Trials Database (EudraCT), clearing the way for the agency’s long-promised goal of making summary clinical-trial results publicly available through the EU Clinical Trials Register (EU CTR).
Clinical-trial sponsors are being “encouraged” to register on the EudraCT website so they can begin uploading summary results. These results will start to be available to the public once the EMA has launched the complementary new version of the EU CTR towards the end of this year, it notes.
Mandatory posting of summary results, within the terms set out in a European Commission guideline published last year, will not take effect until the middle of 2014, once the EMA has made further updates to the 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.
Retroactive results
The EMA’s announcement, and the voluntary basis for uploading results of past clinical trials – the new EudraCT feature will “allow sponsors to provide summary results of all interventional trials already published in the EU CTR”, the agency says – only goes part way towards addressing transparency campaigners’ concerns about the lack of retroactive information on clinical trials in Europe.
Campaigners such as AllTrials have complained about what they see as the EMA’s foot-dragging on the EU Clinical Trials Register, as well as the register’s limited scope (only Phase II to IV trials included).
They have also called for measures to ensure that, at the very least, summary results from all past trials of medicines currently in use are immediately made available to the public through a clinical-trial register.
Ultimately the AllTrials campaigners would like to see data-sharing from trials going back at least two decades to inform current treatment decisions.
Data access
The EMA plans to introduce from the beginning of next year a tiered system of access to clinical study reports and raw trial data once the agency has published its European Public Assessment Report on an application for centralised marketing authorisation.
However, that system – which has been challenged by pharmaceutical industry associations on a number of grounds – would not apply retroactively.
Nor would provisions introduced in parliamentary amendments to the European Commission’s proposed regulation on clinical trials. These would require sponsors to publish full clinical study reports once a marketing-authorisation decision had been taken.
Under the proposals endorsed by the Parliament’s Environment Committee, trials would also have to be registered on a publicly accessible EU database and their main findings reported within a year of the study ending.
(This latter provision is in line with the Commission’s original text, under which sponsors would have to submit a “summary of results” to the EU’s clinical-trial database within one year of a study ending.)
Initial step
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.
Late arrival
The EU Clinical Trials Register was originally 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 would have to await the launch of Version 9.0 of the database. The aim was to introduce the summary results feature on EudraCT in late 2012, based on the Commission’s guideline.
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 added in March 2011.
Summaries of clinical trial results have been a feature of ClinicalTrials.gov, the public online registry run by the US 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”.
