BioCentury
ARTICLE | Politics & Policy

FDA announces PRO compendium

April 2, 2015 2:06 AM UTC

At an FDA workshop to discuss clinical outcome assessments, the agency said it plans to publish an online compendium of clinically acceptable patient-reported outcomes (PROs). The compendium will include PROs used by companies to support a label claim for drugs approved in 2003 and beyond, as well as PROs that have gone through the FDA's qualification process.

The agency said the compendium will help inform industry of available PROs that could be used in clinical trials, and that companies should then discuss the PRO choices with the agency before using the measures in new clinical trials. ...