Creative image based on a PRO
Can a main creative image of an ad be based on a PRO (related to functionality) that is only listed in the TMA as a component of a primary endpoint (data included in the TMA but statistical analysis only included in the primary publication).
Jennifer Carroll last edited by
This question cannot be answered as a general question. We would need to assess the TMA content, claim and data within the published study. We suggest submitting as an opinion for a formal review.
From a general question perspective, we refer you to the PAAB Guidance on Patient Reported Outcomes which outlines specific considerations for PRO, including specific domains/items comprising the PRO instrument.