Thank you so much for your response!
M
megancouture
@megancouture
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.
Posts
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Calculations based on PM/pivotal trial data -
Calculations based on PM/pivotal trial dataIs it acceptable to include data in an APS that had to be calculated based on PM/pivotal trial data?
e.g., inclusion of 95% CI error bars in a chart that were calculated using the PM-provided SE and sample mean, or calculating reduction/increase in a primary endpoint from baseline to timepoint X when only the mean change at timepoint X and baseline values are in the PM.
Thanks in advance!
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Consensus GuidelinesHi @Jennifer-Carroll , thank you so much for confirming!
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Consensus GuidelinesHi there,
I am working on an APS that will include consensus guidelines recommendations. Unfortunately, the actual published guidelines are a bit hard to digest due to word order and grammatical issues. Are we allowed to reorganize a clinical recommendation's wording such that it is clearer, or do recommendations need to be verbatim pulled from their publications? We intend to keep wording consistent, but we wish to reorder and split it into bullet points rather than a lengthy sentence.
Thank you in advance!