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.
417 - Hi Patrick, Can a company position its brand (from both a creative and messaging standpoint) on secondary outcomes in its PM? If not, then what code number does this contravene?
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There are a multitude of statistical and qualitative reasons to generally tread lightly with secondary endpoints. Nonetheless, it is sometimes possible for a secondary endpoint to be emphasized as the key creative in an APS depending on factors relating to the study, the particular endpoint, and the TMA. It is not possible to list all potential scenarios in which this is acceptable and unacceptable. Seeking a written opinion from PAAB (see the fee schedule on our website) is likely a good starting point when attempting this to ensure that you are walking down a productive path. Some reasons I've encountered over the past few months for which it has not been acceptable to focus on the secondary endpoint from the PM include (PAAB s3):· The secondary endpoint was only accepted in the context of the primary endpoint (e.g. for clarity, to avoid over-selectivity, or because the primary endpoint was directionally different)· Emphasis on this particular secondary endpoint (rather to some other secondary endpoint) was overly-selective· The endpoint extends beyond the indication· the study is located somewhere in the PM other than the clinical trial section of the PM (e.g. in the pharmacology section of the PM)· The endpoint is particularly sensitive to type I error and this wasn’t controlled in some way· There is also an important limitation in the TMA relating to this particular endpoint· There is no statistical analysis done with this endpoint.
