@jennifer-carroll Great, thank you!
L
laraholmes
@laraholmes
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Posts
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Placing PSP enrolment forms on patient websites -
Placing PSP enrolment forms on patient websitesAre we permitted to include links to downloads of PSP enrolment forms on patient websites?
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The use of secondary endpoints with nominal p-values@jennifer-carroll Amazing, thank you so much!
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The use of secondary endpoints with nominal p-valuesIf a product would like to include secondary endpoint data from one of their pivotal trials that is not included in the TMA, but the endpoint does meet the requirements for inclusion as per the PAAB guidance document on the use of secondary endpoints (i.e., it is a validated instrument/in another product's TMA/etc.), but it only has a nominal p-value associated with the results, could it be used in APS? If it were to be presented secondary to the primary endpoint, it was clearly disclosed that the p-value was nominal and in a claim-neutral manner?
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Separation of patient consent information on a PSP form@jennifer-carroll Thank you very much for the very comprehensive and helpful response!
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Separation of patient consent information on a PSP formlaraholmes 28 Feb 2025, 11:11
Is patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
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Separation of patient/HCP information on PSP formsIs patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
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Use of actual patient imagesWould it be possible to include before and after patient images of a patient from a product's pivotal trial only in an APS? Or would data reflecting what the images are showing (e.g., skin clearance) be required to "quantify" the images?
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Format of patient toolsIf we have a medication that is delivered by a device, could we create a brochure that is in the shape/size of the device? The idea is that it would be a tool that contains FAQs that the HCPs would use to counsel patients and one of the purposes of the tool would be to show patients what the device looks like/its size via the tool.
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Advisory on the Use of Open Text Fields in APS@admin @Jennifer-Carroll Can you please clarify if having a "blank" open text field for a greeting is acceptable in this respect? I have received conflicting responses from reviewers on the acceptability of such an option.
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Advisory on the Use of Open Text Fields in APS@admin @Jennifer-Carroll Can you please clarify if having a "blank" open text field for a greeting is acceptable in this respect? I have received conflicting responses from reviewers on the acceptability of such an option.