Repercussions of Europe’s New Regulations for Release of Clinical Trial Data


In two posts on PLOS Blogs, Tom Jefferson of the Cochrane Acute Respiratory Infections Group in Italy reviews the European Medicines Agency’s new regulations governing the public release of data and internal reports from clinical trials of pharmaceutical drugs, and discusses how the regulations will apply to accredited researchers and the general public.

“The practical importance of the policy hinges on the dawning realization of the difference in accuracy, completeness and trustworthiness of published versions of trials compared to their (clinical study report) counterparts,” writes Jefferson. “Trials may not be published, some may not even be registered (especially the older ones) posing decades-old problems for readers, users and, from my point of view, evidence synthetisers.”

EMA’s Release of Regulatory Data: Possible Fall out for Journals and Research Synthesis (Speaking of Medicine, PLOS One Blogs, November 3, 2014)