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    Creative image based on a PRO

    Claims & Support/References for Claims
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      HealthyMind last edited by

      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 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @HealthyMind last edited by

        Hello @healthymind

        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.

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