Bioethics News

Europe’s Drug Regulator Opens Vaults of Clinical-Trials Data

October 26, 2016

(Nature) – In a move lauded as a landmark for transparency in medical science, the London-based European Medicines Agency (EMA) has begun to publish details of the full clinical-trial data that it receives from pharmaceutical companies. On 20 October, the agency published some 100 clinical reports about two EMA-approved medicines (carfilzomib, a cancer drug, and lesinurad, a gout treatment) that together run to around 260,000 pages. The disclosures make the EMA the first major drug regulatory agency to publish the warts-and-all results of clinical investigations that drug developers submit when they apply for the agency’s approval to market medicines in the European Union.

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