A pragmatic overview will be provided that delineates the series of activities necessary to properly develop and implement a patient-reported outcome (PRO) measure in a clinical trial for the purposes of product approval and labeling. During this interactive forum, a real-world example will be used to illustrate the considerations and associated resources that a clinical trial sponsor may face when using a PRO instrument as an efficacy endpoint.

Learning Objectives:
Define the various steps in developing PRO instruments suitable for product approval and labeling
Describe the considerations related to the implementation of a PRO measure in a clinical trial
Identify the procedures for obtaining FDA feedback on PRO instruments intended to support claims in medical product labeling.