EMA Makes Concessions to Transparency Advocates Over Release of Clinical Study Reports
October 3, 2014 | The European Medicines Agency (EMA) has finalized its policy on clinical study transparency, following an April vote of the European Parliament to require all clinical trial results to be openly published. The EMA's proposals for handling this release of clinical trial reports to the public have previously met with pushback from transparency advocates, as reported by Clinical Informatics News. The finalized plan walks back some of the most controversial policies: most importantly, the EMA has reversed its decision to only allow access to trial data within a dedicated online portal, and will now permit users to download, print, and share study reports. The agency has also clarified that it, and not pharma companies, will have final say on what information from study reports can be redacted, although critics of the agency still maintain that any redaction is unacceptable. Clinical trial results are set to become public starting in January 2015. PharmaTimes