AllTrials – EMA removes some restrictions from its data sharing policy

"After pressure from citizens and scientists the European Medicines Agency has agreed to scrap restrictions on clinical trial data sharing that would have made independent scrutiny of the data impossible. Hundreds of citizens and organisations representing thousands of people across Europe have been asking the EMA to overturn a rule that would have allowed researchers to view Clinical Study Reports (CSRs) on screen only. CSRs are documents produced for regulatory purposes and often contain thousands of pages of complex information. Researchers would not have been able to print, download, save or share these, making their work analysing benefits and harms of medicines virtually impossible. At a Management Board Meeting today the EMA agreed to remove this restriction from its final data sharing policy ..."