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
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- 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.
Side-by-side comparison of clinical study methodologies
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Without mentioning any clinical data or making any clinical claims, would it be permitted to compare the methodologies of the pivotal studies of 2 products. For example, Product A's study has a primary efficacy endpoint at week 1 and Product B's has a primary efficacy endpoint at week 8. Or, something, like Product A included patients over 65 and Product B excluded them.
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Happy Monday @charlton
No. This would not be an acceptable comparison. See Q&A 674 and Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?.
