Pooled long-term extension data
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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?
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Good Morning @HollyMed
Pooled data is not acceptable even if part of a pre-planned long-term extension study.
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Hi @Jennifer-Carroll. In your response to question 762, you mention that one of the circumstances in which PAAB will accept pooled analysis as stand-alone evidence for a therapeutic claim is when it is preplanned. However, in this scenario, you’ve indicated that data from a preplanned open-label pooled LTE is not acceptable. Could you please clarify the distinction and explain why this particular case does not meet the criteria?
