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  4. Regarding the use of PROs in promotional materials:
PAAB Notice
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.

Regarding the use of PROs in promotional materials:

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • G Offline
    G Offline
    GeoffLS20
    wrote on last edited by
    #1

    In cases where a PRO is not contained in the TMA and is not the primary endpoint (but is a reliable and valid pre-defined endpoint and is consistent with the primary endpoint), does the PRO need to be designated as a key secondary outcome in order to be included in promotional materials? Additionally, generally speaking, under what circumstances would the disclosure of other failed secondary endpoints be required?

    Jennifer CarrollJ 1 Reply Last reply
    1
    • G GeoffLS20

      In cases where a PRO is not contained in the TMA and is not the primary endpoint (but is a reliable and valid pre-defined endpoint and is consistent with the primary endpoint), does the PRO need to be designated as a key secondary outcome in order to be included in promotional materials? Additionally, generally speaking, under what circumstances would the disclosure of other failed secondary endpoints be required?

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

      Hello @geoffls20

      The document Guidance on Patient Reported Outcomes provides the limitations for use of PROs. It is not required that the study identifies it as a “key” secondary endpoint. Note that it must be identified as a “secondary endpoint” and this must be disclosed in the APS per code section 3.1.10.

      The discloser of failed secondary endpoints is required when they are closely related to the other endpoints so as not to be selective. (s.5.12)

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