European regulator to release all data from clinical trials


The European Medicines Agency (EMA) is currently implementing a policy of publishing all the clinical data it receives from pharmaceutical companies, in a bid to promote transparency in clinical trials.

The EMA, which acts as the European Union’s regulator for drugs and medical products, says that it intends to release all Clinical Study Reports in applications that have been submitted since 1 January 2015, whether or not the applications were approved, rejected or withdrawn.

Earlier this week the agency published published some 100 clinical reports about two EMA-approved medicines (carfilzomib, a cancer drug, and lesinurad, a gout treatment).

The EMA’s CSR policy — which it adopted in 2014 — “will benefit academic research and the practice of medicine as a whole", says EMA executive director Guido Rasi.

The policy shift comes in the wake of an ongoing campaign by lobbyists to have all trials registered and results reported.

Some 700 medical and patient organizations had lobbied for the data release under the auspices of the AllTrials campaign.

The US branch of AllTrials is actively lobbying the Food and Drug Administration to adopt a similar policy to the EMA.




MORE ON THESE TOPICS | clinical research, clinical trials, transparency

This article is published by Xavier Symons and BioEdge under a Creative Commons licence. You may republish it or translate it free of charge with attribution for non-commercial purposes following these guidelines. If you teach at a university we ask that your department make a donation. Commercial media must contact us for permission and fees. Some articles on this site are published under different terms.

 
 Search BioEdge

 Subscribe to BioEdge newsletter
rss Subscribe to BioEdge RSS feed

 
comments powered by Disqus