Europe Issues Policy on Access to Clinical Trial Data, Criticisms Continue

The European Medicines Agency has announced in a press release its final policies on the open publication of data from clinical trials. Ed Silverman of WSJ Pharmalot reports that the policies are still being widely criticized by people who would like trial data to be accessible to the public for independent evaluations of safety and effectiveness of medications.

“The EMA did address one concern – researchers will be allowed to print information instead of being restricted to viewing data on computer screens – which was greeted with relief by critics who lobbied to lift the restriction,” writes Silverman. “The most controversial part of the policy, though, centers on redacting commercially confidential information, which has been a hot-button issue all along.”

Mickey Nardo weighed in on the important decisions in a series of posts on his blog 1 Boring Old Man, as did Tom Jefferson in the British Medical Journal Blog, and also AllTrials.

EMA Remains Under Fire for its Policy on Disclosing Clinical Trial Data (WSJ Pharmalot, October 3, 2014)

anything but over… (1 Boring Old Man, October 9, 2014)

Tom Jefferson: EMA’s release of regulatory data—trust but verify (BMJ Blogs, October 7, 2014)

Publication of clinical reports: EMA adopts landmark policy to take effect on 1 January 2015 (European Medicines Agency Press Release, October 2, 2014)

EMA removes some restrictions from its data sharing policy (AllTrials, October 3, 2014)