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 Endpoint Presentation
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Section 3.1.10 of the code notes "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." We are unclear about the "when warranted" portion of this statement. Assuming the primary outcome of a study was achieved, would the data/outcomes of this primary endpoint need to be specified if a secondary endpoint is the focus of a promotional tool, in a case when the study is not included in the product monograph? All other parameters of the study, such as patient population, indication, etc., are consistent with the product monograph.
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Hello @Maha-Dogar
Thanks for your question. Please note that this topic has been addressed previously. Searching “secondary endpoints” in the forum should provide the relevant guidance. Note that the response applies regardless of whether or not the study appears in the TMA.
