Secondary Endpoint Presentation
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Section 3.1.10 of the code notes "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." We are unclear about the "when warranted" portion of this statement. Assuming the primary outcome of a study was achieved, would the data/outcomes of this primary endpoint need to be specified if a secondary endpoint is the focus of a promotional tool, in a case when the study is not included in the product monograph? All other parameters of the study, such as patient population, indication, etc., are consistent with the product monograph.
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Hello @Maha-Dogar
Thanks for your question. Please note that this topic has been addressed previously. Searching “secondary endpoints” in the forum should provide the relevant guidance. Note that the response applies regardless of whether or not the study appears in the TMA.
