Using RWE as support for a comparison claim
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Hi PAAB, I saw your guidance on the use of RWE here (https://www.paabtraining.com/rwe.html) and I am wondering if this extends to 'high quality' studies in which the efficacy of two or more products is compared? For example - an observational study including data from patients using several products? Thank you for your time!
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Hi PAAB, I saw your guidance on the use of RWE here (https://www.paabtraining.com/rwe.html) and I am wondering if this extends to 'high quality' studies in which the efficacy of two or more products is compared? For example - an observational study including data from patients using several products? Thank you for your time!
Good Morning @gbrl88
Apologies for not seeing this sooner. Thank you for bringing this document to our attention. This informational piece was put out while we were discussing proposed changes to the use of RWE. However, the proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising. As such, we will be taking the document referenced above, down.
As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.
