April 24, 2024

European regulator to release all data from clinical trials

The European Medicines Agency (EMA) will now publish all clinical trials data.

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applications that have been submitted since 1 January 2015, whether or not the applications were approved, rejected or withdrawn.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.

European regulator to release all data from clinical trials
Xavier Symons
Creative commons
clinical research
clinical trials