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.
Definition of a pivotal trial
-
Hello, could you please provide a brief explanation of what constitutes a "pivotal" trial, as this term is widely used but does not appear in the PAAB code? Thank you.
Happy Friday @username
The PAAB interprets “pivotal trial” to mean that the study was important to this specific product getting the indication (not necessarily important to the therapeutic area overall).
