Patient Reported Outcomes (PROs) are described by the U.S. Food and Drug Administration (FDA) as, “A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else.” PROs are a critical mechanism for understanding, monitoring, and managing a patient’s treatment-related adverse events (AEs), as they capture first-hand understanding of patient experiences.
Read more about Friends’ work to incorporate PROs in assessments of tolerability and dosing.