Recently we've seen an APS that have been submitted where p-values were requested for safety data, otherwise it would not be admissible as data. The problem is, virtually no clinical trials power their adverse events to generate p-values. When did this become a requirement?

PAAB section 5.9 has required statistical analysis to support inclusion of comparative therapeutic data from clinical trials (whether active comparator or inactive comparator) for as long as I can remember. You might be thinking of comprehensive excerpts from the s/e tables of part 1 of the PM (which don’t require stats). PAAB can also consider claim neutral, non-comparative presentations of the incidences of sponsor drug’s side effects from an acceptable clinical trial provided those incidences are roughly aligned with the product monograph AND the product monograph’s most common adverse events (with incidences) are presented as copy specific balance copy.


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