Before/After Patient Images | Branded Context
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We are looking to highlight before and after patient images (i.e., before and after treatment) in a branded context. Specifically, these would be real patients from a clinical trial that is included in the Product Monograph, and the results they are demonstrating would be consistent with outcomes from the specific trial. The images themselves are not in the Product Monograph and may or may not be in the trial publication—some may be leveraged from data on file. Our question is two-pronged:
- What degree of evidence (beyond a signed Med/Reg letter confirming the accuracy of the images) would be needed to support the inclusion of these images in a branded APS?
- Are there any stipulations regarding the context to where these images must be placed in an APS?
Thank you!
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Good Morning @matt-s17
Apologies for the delayed response.
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In addition to a letter from med/reg confirming that they are actual patients, the presentation would be required to include the statistically significant data from the study for the endpoint being presented. The images should therefore reflect the average response. It would not be acceptable to select images that show the best-case scenario for patients.
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The pictures would also have to be disclaimed with “Actual patient. May not be representative of all patients.”. As with patient images, they should only appear in a clinical context and with the supporting data (e.g., if you’re going to place them on a summary page, the quantification will require repeating).
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