Regulatory Focus™ > News Articles > New Updates to EMA Database Will Soon Make Summary Results of Clinical Trials Public

New Updates to EMA Database Will Soon Make Summary Results of Clinical Trials Public

Posted 11 October 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has announced a major update to a system used to release clinical trial information to the public, saying its European Clinical Trials Database (EudraCT) will soon be capable of releasing summary results to the public.

The new update, dubbed EudraCT V9, adds to the existing EudraCT system, which already contains sponsor-submitted clinical trial protocols and is "substantially aligned" with systems maintained by foreign regulatory authorities like the US' ClinicalTrials.gov.

"As of today, clinical-trial sponsors are encouraged to register on the EudraCT website to start uploading summary results," EMA wrote. Participation is at this time still voluntary, but the system is expected to be required in mid-2014.

"Results posted by sponsors in EudraCT will start to become publicly available once the Agency has launched the complementary new version of the EU Clinical Trials Register (CTR) towards the end of the year," EMA explained. "The content and level of detail of the summary results is set out in a European Commission guideline and in its technical guidance."

The end goal is to move beyond having just basic protocol information in the registry, and toward a system that allows the public to track the end results of trials, including those with negative results.

EMA is currently involved in a fierce legal battle with several companies over its plans to require the release of clinical data submitted in support of marketing applications. While those larger plans have been on hold pending the resolution of a lawsuit, the EudraCT update represents something of a more immediate interim effort on the part of regulators.

"The Agency 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," EMA added.


EMA Announcement


Tags: EudraCT, EU

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