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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Creative image based on a PRO

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • H Offline
    H Offline
    HealthyMind
    wrote on last edited by
    #1

    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 CarrollJ 1 Reply Last reply
    0
    • H HealthyMind

      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 CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      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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