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Curious about responder rates... There was a post-hoc analysis done of the responder rates for the product's use (that the indication was studied and approved for), answering the question "How many patients in the trial were able to achieve the result that the overall trial demonstrated?". The data is specific to the % of patients that were able to achieve a specific reduction in symptoms (as was the phase 3 study design).

For example the trial looked at Product A's ability to lower intraocular pressure. Overall, patients achieved a mean reduction of 30% by month 3. In the responder rate data, we can see that 80% of patients in the trial achieved a 25% or greater reduction by month 3.

This responder rate data isn't in the PM, but we do have the data on file. Would this be considered off-label?

@jennifer-carroll
Hi Jennifer,
I realize this topic is a little old, however I was hoping for guidance on a similar topic; patient preference claims.

Is patient preference seen as different from patient satisfaction? Let's say in a comparative trial we asked patients which of the two products would they prefer to continue using... could we then say "XX% of patients preferred product ABC vs product DEF for the treatment of...." ?