Before-after images from real world patients in branded context
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Re: Before/After Patient Images | Branded Context
Hi @Jennifer-Carroll, I had a question related to a previous "Before/After patient image" question (linked above).
Let's say you wanted to include b/a images of real patients (i.e., before/after treatment in a branded context) but the patients were not from any trial.
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Would this change your answers to the questions asked in the topic linked above? Or does whether they are/are not from the pivotal trial (or any trial) not matter?
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If it does matter, are there any other differences (beyond the questions asked in the referenced topic) that we would need to be aware of?
Thank you!
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Re: Before/After Patient Images | Branded Context
Hi @Jennifer-Carroll, I had a question related to a previous "Before/After patient image" question (linked above).
Let's say you wanted to include b/a images of real patients (i.e., before/after treatment in a branded context) but the patients were not from any trial.
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Would this change your answers to the questions asked in the topic linked above? Or does whether they are/are not from the pivotal trial (or any trial) not matter?
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If it does matter, are there any other differences (beyond the questions asked in the referenced topic) that we would need to be aware of?
Thank you!
Hi @kshulist
A similar answer would apply. We would ask medical/regulatory to confirm that this was an actual patient that was treated per the TMA for the indicated use, appropriate dosing, etc. and the after results would still be required to reflect the average result from the pivotal trial(s). The supporting data would be required in the APS along with the noted disclaimer and other elements per the previous referenced question.
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Hi @kshulist
A similar answer would apply. We would ask medical/regulatory to confirm that this was an actual patient that was treated per the TMA for the indicated use, appropriate dosing, etc. and the after results would still be required to reflect the average result from the pivotal trial(s). The supporting data would be required in the APS along with the noted disclaimer and other elements per the previous referenced question.
@jennifer-carroll Thank you!
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Hi @kshulist
A similar answer would apply. We would ask medical/regulatory to confirm that this was an actual patient that was treated per the TMA for the indicated use, appropriate dosing, etc. and the after results would still be required to reflect the average result from the pivotal trial(s). The supporting data would be required in the APS along with the noted disclaimer and other elements per the previous referenced question.
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@jennifer-carroll assuming the patient profile meets all these conditions, does it have to be a real photo, or would an AI generated image based on the before and after clinical results for patient be acceptable?
Hello @constance
Fictitious images are considered acceptable. Patient images demonstrating effect which are not actual patients (AI generated or otherwise) should always be disclaimed as such. We would also recommend considering the Government of Canada document The Artificial Intelligence and Data Act (AIDA) voluntary code.
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Hi @kshulist
A similar answer would apply. We would ask medical/regulatory to confirm that this was an actual patient that was treated per the TMA for the indicated use, appropriate dosing, etc. and the after results would still be required to reflect the average result from the pivotal trial(s). The supporting data would be required in the APS along with the noted disclaimer and other elements per the previous referenced question.
@jennifer-carroll, I have another follow-up question related to this. I understand that for all before/after images (real-world patients, AI-generated images, pivotal trial patients) the after results need to reflect the average result from the pivotal trial. Is it enough that the images clearly look like they reflect the average result, or does PAAB require the patient's actual data values to confirm this (for example, the baseline and "after" endpoint scores/values). For real-world patients, doctors may not be as vigilant at recording this info as when they are an investigator in a clinical trial. Thanks so much for your help!
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@jennifer-carroll, I have another follow-up question related to this. I understand that for all before/after images (real-world patients, AI-generated images, pivotal trial patients) the after results need to reflect the average result from the pivotal trial. Is it enough that the images clearly look like they reflect the average result, or does PAAB require the patient's actual data values to confirm this (for example, the baseline and "after" endpoint scores/values). For real-world patients, doctors may not be as vigilant at recording this info as when they are an investigator in a clinical trial. Thanks so much for your help!
Hey @kshulist
An image that supports the evidence presented in the piece from an RCT, would be considered acceptable even if it was from a patient in an RWE trial. PAAB does not request confirmation that it is from a patient in the trial being presented who had the average response. The visual simply needs to reflect what would commonly be seen as “consistent with” the magnitude of effect demonstrated in the RCT.
If the evidentiary basis of support is the RWE, use of the images would not be acceptable.
