What is a PRO (Patient-Reported Outcome)?
We use the FDA’s definition : “Any report coming directly from patients about a health condition or treatment” (from FDA 2006, Draft Guidance for Industry. Patient-Reported Outcomes measures: use in medical product development to support labeling claims.) Therefore, even objective data recorded by the patients will be found here (such as Forced Expiratory Volumes, etc.). We also include proxy- and caregiver-reported measures, especially to take into account the cases when the patient is not able to self-report, such as pediatric studies or mental disorders. On the other hand, results collected with interviewer-administered instruments, as well as clinician-reported evaluations will not be found in this database.
