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.
Final analysis in APS
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If our TMA includes our 2nd interim analysis (median duration of follow-up was 18 months) and our final analysis is now published (median follow-up was 40 months at study end), can all data points from the final analysis be included in the APS?
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If our TMA includes our 2nd interim analysis (median duration of follow-up was 18 months) and our final analysis is now published (median follow-up was 40 months at study end), can all data points from the final analysis be included in the APS?
There may be opportunity to include the final analysis providing it meets all the requirements set forth in our Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising. As we do not have the actual TMA and published paper for review, we are unable to provide a definitive answer. We suggest submitting an opinion if you remain unclear after consulting the guidance document.
