Can you clarify what parameters to keep in mind when it comes to scales used for efficacy endpoints in RWE studies vs. in the pivotal trials. Ex. Is there an issue if pivotal studies use EGSS and RWE uses IGA?
D
Danielle
@Danielle
Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Posts
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RWE Usage -
Third-Party Unbranded Patient App - CommunicationsWould a leaflet that explains the benefits of a third party developed patient app being disseminated to patients via a branded PSP require PAAB review? The leaflet would not mention the specific PSP or brand. It would only discuss the app. The app itself was reviewed as part of a branded patient brochure under 'addition lifestyle resources' and was deemed acceptable by PAAB.
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133 - Can a non-gated medical journal web site, whose online advertising is restricted to reminder ads and non-pharma ads, offer unrestricted access to a complete digital version of back issues of the journal (Rx advertising would appear as it does in print)?@jennifer-carroll Hi Jennifer, does a reminder ad with indication statement running in a specialty pub require anything more if the drug has a black box warning? Only brand colours and logo would be used, no creative/visuals.
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Patient Lifestyle AppsHello,
I'd like to understand how lifestyle apps can be leveraged in branded patient materials when cited as available resources and or lifestyle support apps produced by third parties, including authoritative sources and independent 3rd parties. ie. the apps are not brand specific but would be cited as available resources for patients within a branded patient tool.
Is there any difference if the apps focus on: (1) lifestyle and nutrition (2) lifestyle, nutrition and disease informationLastly, does context change if access to the app is only provided via a PSP program but the app remains developed by a 3rd party with the manufacturer having no ownership over the app or the app content.
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Bill 92Hello,
We would like to understand any rule/restrictions around communicating that a particular patient assistance card being distributed in Quebec is not affected by the new Bill 92. For example, would language such as '...not impacted by Bill 92 and can still be used at Pharmacies across Quebec.' be approvable?Danielle
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Patient Satisfaction ClaimsWe are looking to better understand if patient satisfaction claims can be used in the context of HCP communications. If so, could you please specify the parameters we would need to consider? The brand does not have a PSP. Could a patient be surveyed by a third party to determine non-subjective satisfaction measures? Is there an ability to also survey around perception of efficacy, tolerability, ease of use, and preference?