Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency
Date of article: 16/05/2014
Daily News of: 19/05/2014
Country: EUROPE
Author: European Ombudsman
Article language: en
In a letter to the European Medicines Agency (EMA), the European Ombudsman, Emily O'Reilly, has expressed concern about what appears to be a significant change of policy concerning clinical trial data transparency. According to documents the Ombudsman has seen, EMA is planning to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen on screen using an interface provided by EMA, as well as imposing wide restrictions on the use of such data."