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 with using the products. London-based GlaxoSmithKline and AstraZeneca, for example, have encountered legal problems regarding the concealment or misrepresentation of data pertaining to psychiatric drugs.
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.