Use of real MRI scans in APS
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My client would like to work with KOLs to include real MRI scans for an APS. The scans would be of patients that fit in the product's indication. An agreement would be obtained to use the scans, yet we would use a fictional name for the patient. Are there any other considerations that we would need to consider from a PAAB perspective? Would we need a letter from the medical department to confirm that the scans fit the indication?
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I forgot to mention that we would use these in both branded and sometimes unbranded tools.
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Hey @NatBourre
When images are presented they must be aligned with the indication. If they present an outcome, data to support this effect must be presented within the APS. A letter from medical/regulatory should be provided to confirm that the demonstrated effect in the image is aligned with/representative of the effect demonstrated in the trial (i.e. the average not the best-case scenario).
It would not be acceptable to use the same images in both branded and unbranded advertising as when you link branded and unbranded, everything becomes branded. The images and their presentation in the unbranded pieces would have to be different.
