Guidance: Patient-Reported Outcomes

September 15, 2009


This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials.
It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling.

PRO instruments provide a means for measuring treatment benefits by capturing concepts related to how a patient feels or functions with respect to his or her health or condition.

The concepts, events, behaviors, or feelings measured by PRO instruments can be either readily observed or verified (e.g., walking) or can be non-observable, known only to the patient and not easily verified (e.g., feeling depressed).