Closing Humira Inquiry, Ombudsman Advises EMA On Future Trial Data Redaction
This article was originally published in SRA
Executive Summary
The European Ombudsman, Emily O'Reilly, has closed her inquiry into the European Medicines Agency's release of a number of redacted clinical trial study reports on AbbVie's MAb Humira (adalimumab), and has made a number of recommendations as to what the agency needs to do to ensure that the maximum amount of trial data is made publicly accessible in future1.