Clinical Trial Transparency in Europe?

The regulatory body that licenses drugs for use in the European Union is devising a policy that will require the publication of some clinical trial data.

Bob Grant
Bob Grant
Mar 28, 2013

WIKIMEDIA, PARENTING PATCHMounting pressure for transparency in the drug approval process has led the European Medicines Agency (EMA), which is the European Union’s equivalent of the US Food and Drug Administration, to mandate the publication of clinical trial data submitted by drug companies. The EMA is expected to institute such a policy by January 1, 2014, according to Nature. Next month, UK trade groups and professional organizations will meet in London to talk about the impending increase in openness. “We should all stop discussing whether [the issue of clinical trial data transparency is] important or not and start having practical discussions about how we move forward,” Nicola Perrin, head of policy at the Wellcome Trust, told Nature.

British drug makers have faced pressure in recent years to be more forthcoming with clinical trial data that may better inform the public of the effectiveness and potential dangers associated...

The particulars of the new policy are as yet unclear, and details such as how, when, where, and in what form data will be released to the public have yet to be ironed out.