responder rates
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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?
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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?
Hello @hannah
There is insufficient information to determine if the data would be considered off-label, but there is sufficient information to determine that it would not be acceptable data as post-hoc analyses are not considered high quality evidence. Per code section 3.1.1, clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable. As the data on file in this case is not in the TMA (PM), it is not acceptable for advertising claims.
