Use of Patient Reported Outcomes for Substantiation of Structure Function Claims

As the use of consumer surveys and subjective questionnaires grows in the clinical trial space, Patient Reported Outcomes (PROs) are gaining attention as tools for substantiating structure/function claims on food and dietary supplement products. This white paper, authored by Dr. Corey Hilmas and Andrew Charrette of KGK Science, explores how PRO instruments—particularly PROMIS® tools—can be used effectively, their regulatory limitations, and how to balance subjective and objective endpoints for compliant and credible claims. A must-read for sponsors and product developers looking to leverage PROs in their clinical research strategy.