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!
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Hey @dmauri
Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada.When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).
