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.
Secondary hierarchical endpoints
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Hello,
If a pivotal trial has a secondary endpoint that is predefined and included in the trial description in the monograph, but the data is not included in the monograph due to a failed secondary endpoint higher up in the hierarchical testing structure, is it possible to present the data for this endpoint in a neutral way in an APS (knowing that significance could NOT be claimed for this endpoint)? -
Hello,
If a pivotal trial has a secondary endpoint that is predefined and included in the trial description in the monograph, but the data is not included in the monograph due to a failed secondary endpoint higher up in the hierarchical testing structure, is it possible to present the data for this endpoint in a neutral way in an APS (knowing that significance could NOT be claimed for this endpoint)?Hello @username
Listing the outcomes within the trial design in the TMA does not necessarily qualify it for discussion within a promotional tool. As a general rule of thumb, if there are no valid stats, there is no claim. Data for endpoints past the failed endpoint in hierarchical testing, should not be presented in advertising.
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Hello @username
Listing the outcomes within the trial design in the TMA does not necessarily qualify it for discussion within a promotional tool. As a general rule of thumb, if there are no valid stats, there is no claim. Data for endpoints past the failed endpoint in hierarchical testing, should not be presented in advertising.
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@jennifer-carroll Thank you for your quick reply. Would it be acceptable to disclose this endpoint in an APS when discussing study design, as it would be consistent with the TMA?
Hey @username
In the context of a study design, with no additional weight that would emphasize the endpoint, it would likely be acceptable to mention the endpoint.
