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.
611 - Section 3.1.10 of the Code states that "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." How do you know when presentation of the primary endpoint is warranted? Is it always necessary to present the primary endpoint when presenting data (i.e., a secondary endpoint) that is in the product monograph?
-
It is not always necessary (although it is often necessary). The primary endpoint is required to appear prior to the secondary endpoint when not doing so could mislead the audience in some way. There would be several circumstances in which that could be the case but I’ll present one scenario here to make the point. Let’s say, for example, that non-inferiority versus the active comparator was demonstrated on the primary endpoint in a pivotal trial which is included within the product monograph. It would be misleading to present product monograph superiority data for a secondary endpoint from that same pivotal study without first conveying the fact that the product was non-inferior in the primary outcome. Although, secondary endpoints which are not directionally consistent with the primary endpoint are generally not accepted, the presentation would be acceptable in this case as it is consistent with the product monograph.
