Linking out to clinical trial publications in a neutral manner
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Hi there,
In general, can we use branded emails with no claims to link out to clinical trial publications (not included in the PM) that may not pass PAAB's requirements to support efficacy/safety claims (though we are not using the publications to support any claims)?It might be easier to explain my question with an example:
I understand that to support comparative efficacy and safety claims, publications need to be head-to-head, well-designed, adequately controlled, blinded, randomized. However, let's say we have an open-label H2H (due to different administrations of the drugs) that is not included in the PM. Could we develop a branded email that only says "There was a head-to-head study done" and provides a link to the publication (without any claims at all)?
Or a similar example is for an RTE publication. Let's say the RTE publication would not meet the recently updated PAAB requirements to support efficacy/safety claims. Could we still neutrally link out to it from a branded email ("See a link to recent real world data below")?
Thank you for your help!
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Hi there,
In general, can we use branded emails with no claims to link out to clinical trial publications (not included in the PM) that may not pass PAAB's requirements to support efficacy/safety claims (though we are not using the publications to support any claims)?It might be easier to explain my question with an example:
I understand that to support comparative efficacy and safety claims, publications need to be head-to-head, well-designed, adequately controlled, blinded, randomized. However, let's say we have an open-label H2H (due to different administrations of the drugs) that is not included in the PM. Could we develop a branded email that only says "There was a head-to-head study done" and provides a link to the publication (without any claims at all)?
Or a similar example is for an RTE publication. Let's say the RTE publication would not meet the recently updated PAAB requirements to support efficacy/safety claims. Could we still neutrally link out to it from a branded email ("See a link to recent real world data below")?
Thank you for your help!
Hi @kshulist
Generally, as per PAAB code sections 3.1.1 and 5.7, an APS should not link to a clinical trial paper/publication that does not meet the PAAB criteria for comparative clinical claims and is not featured in the TMA. This includes a neutral presentation that only mentions the study and makes no claims.
For the second example, we understood the "RTE" publication to be “RWE" publication. For RWE studies, the same principle applies. Should the RWE publication not meet the requirements of the RWE document, there should be no linking to such a study from a branded email/other branded APS.
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Hi @kshulist
Generally, as per PAAB code sections 3.1.1 and 5.7, an APS should not link to a clinical trial paper/publication that does not meet the PAAB criteria for comparative clinical claims and is not featured in the TMA. This includes a neutral presentation that only mentions the study and makes no claims.
For the second example, we understood the "RTE" publication to be “RWE" publication. For RWE studies, the same principle applies. Should the RWE publication not meet the requirements of the RWE document, there should be no linking to such a study from a branded email/other branded APS.
@jennifer-carroll Thanks Jennifer!
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Hi @kshulist
Generally, as per PAAB code sections 3.1.1 and 5.7, an APS should not link to a clinical trial paper/publication that does not meet the PAAB criteria for comparative clinical claims and is not featured in the TMA. This includes a neutral presentation that only mentions the study and makes no claims.
For the second example, we understood the "RTE" publication to be “RWE" publication. For RWE studies, the same principle applies. Should the RWE publication not meet the requirements of the RWE document, there should be no linking to such a study from a branded email/other branded APS.
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@jennifer-carroll, I had a follow-up question. Would it be okay to link to publications that do not meet the PAAB criteria from an unbranded email? Thank you!
No, it would not be acceptable to include a study that does not meet PAAB requirements for evidence in branded or unbranded APS. Please note that in general, a study for the sponsor's product would not be considered unbranded, even without the brand name or branding elements.
