university pushed a cautious sigh of relief when the European Medicines Agency (EMA) announced yesterday that he would soften project controversial rules to open the clinical trial data to public scrutiny. In particular, the agency said it will allow researchers "to download, save and print the test data for academic research purposes and not commercial." A previous plan would have allowed only to view the data on their computer screens.
last month, researchers and the European Ombudsman criticized the proposed agency policy for data sharing as too restrictive and impractical. Today, they welcomed the announced changes, but sounded a note of caution, like other controversial elements are likely to remain in the final text.
"This is a good thing. It means the researchers will be able to review, compare and share information on clinical trials. To allow researchers access to information on clinical trials on the screen only have obstructed their work, "said Síle Lane, director of campaigns in the UK pressure group Sense about science, in a statement today.
But in an email sent to science Insider today, European Ombudsman Emily O'Reilly said she did not know if the agency responded to its remaining concerns and "consider carefully" the final text. The draft rules "imposed broad legal requirements" on data access and use, and a "limited only authorized access to clinical trial data by expunge important information," says O'Reilly.
"The Ombudsman remains puzzled as to why EMA has abandoned its original policy the Disclosure Project in 2012 and replaced by a different political project, more in line with industry wishes pharmaceutical, "his email statement added.
spokesman EMA Martin Harvey-Allchurch said the policy stems from a long consultation process." We listened and we tried to come what we think is a viable solution, "he said. the final text should be adopted in mid-July, before the new rules are implemented in October.
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