Dosing information and off-label competitors in retrospective cohort studies
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Hello! We have come across multiple retrospective cohort studies that could potentially be used in APS, thanks to PAAB's Guidance on RWE. One issue that has come up for a couple of these studies is the lack of dosing information, which is required to fulfill 1.1.3 of the RWE Guidance. We believe that it is common for specific dosing information to be omitted from these studies, but think that it is fair to assume that a large majority of the patients would be dosed based on regional labels (e.g., SmPC, US PI). For such studies where dosing information is not available, can we simply cite the regional label?
Another consideration for a couple of these studies is the use of a "SoC" comparator pool, in which of some of the SoC treatments lacka Health Canada-approved indication that aligns with the study. Would this contravene 1.7 of the RWE guidance?
Thank you for your help!