The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
Side-by-side comparison of clinical study methodologies
Miscellaneous
2
Posts
2
Posters
41
Views
1
Watching
-
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.
-
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?.
