domingo, 23 de octubre de 2016

European regulator to release all data from clinical trials

European regulator to release all data from clinical trials

Bioedge

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applications that have been submitted since 1 January 2015, whether or not the applications were approved, rejected or withdrawn.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

Bioedge

We goofed and we're eating humble pie. Wednesday, October 19, was World Bioethics Day. I'm afraid that it passed unnoticed at BioEdge, perhaps because every day is World Bioethics Day here. But was also the first time it was celebrated, so we shall be better prepared next year.
However, it appears that very few people were popping champagne bottles in the UK and US even though they must have the larges number of bioethicists. No events were planned in the United Kingdom, only one in the US, and 29 in India. World-wide, there were events in 55 countries, most on the theme of the Day, "human dignity and human rights". 


Michael Cook
Editor
BioEdge



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