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.
Questions regarding 'prognosis'-type claims
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Hi there,
Could you please provide me with some clarity around "prognosis"-type claims in a branded APS. For example, claims like, "People with diseaseA associated with mutationB have a worse prognosis" or "The five-year survival rate of disease A is 40%". (In the first example, the drug would be indicated for patients with diseaseA associated with mutationB).My questions are:
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Can you use these types of claims in a branded sense as long as they are clearly portrayed as "disease information"? And follow-up: would it depend on whether the product has OS data or not?
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These feel like they might fall under the burden of disease guidelines, is that correct (I'm thinking it could be "sequelae")? The BoD guidance says that sequelae for which the product has no data should not be emphasized - does that mean we can still mention them in an unemphasized manner?
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If you can use them in a branded sense, what kind of reference support do you need for them? If (2) is correct, would the references be the same as for burdens in section 3 of the BoD guidance?
Thank you so much for your help!
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Hey @kshulist
- Branded APS can present mortality/prognosis in general terms in the context of disease burden in an un-emphasized manner when there is no product data for mortality/survival, i.e. it is presented among a broad discussion of burdens including those that they have supporting product data for and there is a prominent disclosure included, indicating what the product has not demonstrated an effect in mortality/survival. Please see our disease burden document for additional information.
- This is generally correct. Please see answer to question 1 above.
- Yes, section 3 of the disease burden document provides the required references to establish the burden, e.g. authoritative consensus guidelines.
