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.
Pooled long-term extension data
-
Can you please clarify if pooled long-term extension data can be considered, assuming the original pivotal studies are part of the TMA? I've review the guidance on duration of clinical trials and it seems to assume that the LTE is the continuation of a single study. What if there is a pre-planned open-label LTE where patients from the various pivotal trials are fed into one pooled LTE?
-
Good Morning @HollyMed
Pooled data is not acceptable even if part of a pre-planned long-term extension study.
