Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Use of actual patient images
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Would it be possible to include before and after patient images of a patient from a product's pivotal trial only in an APS? Or would data reflecting what the images are showing (e.g., skin clearance) be required to "quantify" the images?
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Would it be possible to include before and after patient images of a patient from a product's pivotal trial only in an APS? Or would data reflecting what the images are showing (e.g., skin clearance) be required to "quantify" the images?
Hey @laraholmes
All claims, whether implicit (e.g., conveyed through visuals) or explicit, must be supported within the piece. For "before and after" images, data must be provided to quantify the magnitude of the effect suggested by the visuals and should appear at or before the images. Additionally, the images must accurately reflect the data presented, rather than showcasing the best-case outcomes observed in the study.
