It's Up To Stakeholders To Further The PRO Measurement Field, FDA Says
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA is preparing to issue its final guidance on patient-reported outcomes soon, which will codify the agency's approach to validating PROs used as clinical endpoints, but a recent workshop made clear that there is still a substantial amount of work to be done on identifying and creating appropriate measurements of patient-, clinician- and caregiver-reported outcomes