https://www.fda.gov/science-research/focus-areas-regulatory-science-report/focus-area-patient-reported-outcomes-and-other-clinical-outcome-assessments
Focus Area: Patient-Reported Outcomes and other Clinical Outcome Assessments
patient reported outcomesfocus areaclinicalassessments
https://www.allucent.com/resources/case-study/clinical-outcome-assessments-in-multi-cohort-study
Nov 10, 2025 - Explore how Allucent managed complex clinical outcome assessments and recruitment for a multi-cohort study for rare neurodegenerative indications.
clinical outcome assessmentsrareneurodegenerativetrial
https://www.fda.gov/drugs/news-events-human-drugs/fdac-path-pro-consortium-second-annual-workshop-clinical-outcome-assessments-coas-cancer-clinical
The FDA and C-Path have expressed a willingness to leverage their combined strengths for the joint development of this workshop to improve the quality of...
second annualfdapathproconsortium
https://www.fda.gov/about-fda/division-patient-centered-development/clinical-outcome-assessments-coas-medical-device-decision-making
FDA encourages inclusion of clinical outcomes assessments (COA), including patient-reported outcomes (PRO), in the evaluation of medical devices.
clinical outcome assessmentsmedical devicedecision makingcoasfda