TL39: CDRH patient-reported outcomes (PRO) working group
*Pablo E. Bonangelino, FDA/CDRH/OSB 

Keywords: patient reported outcomes, CDRH

The purpose would be to report the findings of the CDRH patient reported outcomes (PRO) working group. The purpose of this group is to understand the statistical features of PRO development and clinical trial use and to make recommendations regarding best practices for using PRO's including training of CDRH statisticians.