Patient profile "interactivity"
Is it possible to have a patient profile tool where the Dr could choose the name for a patient, select on-label disease characteristics, the patient's "occupation" would be randomly selected from an approved list, and the output would be a (properly disclaimed) fictional patient profile?
If so, would each possible permutation be a separate submission?
Jennifer Carroll last edited by
It is possible to allow the doctor to choose aspects of the patient to build a patient case. However, variable elements which may be subject to quantification, would be required to have support within the piece. These are things like goal statements, comorbidities, concomitant therapy, consequences of the disease/condition, or observed outcomes. Also, undue emphasis (e.g. repetition, a common theme/trend, etc.) on any patient characteristic(s), would require product-specific support within the APS. This includes the “occupation” field if there appears to be a theme/trend related to this field.
Each permutation with quantifiable claims would require a separate submission.