Clinical vs. Non-clinical claims
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Hi! I would appreciate if you can provide some clarity on why 'dosage' information is considered non-clinical (when the dosage at which a drug has established efficacy/safety is of clinical relevance). Referring to your response to Q#451, it says " A product’s Health Canada approved indication and dosing is clinically relevant" and it proceeds to say that "Although an individual product’s indication and dosing info is clinically significant, the significance of the incremental difference in indication/dosing between multiple products is generally unknown". Hence from my understanding, this is implying that when speaking of your own drug's dosage it is 'clinical' information, but when comparing dosage of products from multiple TMAs it constitutes 'non-clinical' information. Please help clarify, thank you.
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Hi! I would appreciate if you can provide some clarity on why 'dosage' information is considered non-clinical (when the dosage at which a drug has established efficacy/safety is of clinical relevance). Referring to your response to Q#451, it says " A product’s Health Canada approved indication and dosing is clinically relevant" and it proceeds to say that "Although an individual product’s indication and dosing info is clinically significant, the significance of the incremental difference in indication/dosing between multiple products is generally unknown". Hence from my understanding, this is implying that when speaking of your own drug's dosage it is 'clinical' information, but when comparing dosage of products from multiple TMAs it constitutes 'non-clinical' information. Please help clarify, thank you.
Hello @mhe
The entirety of the response highlights that while “dosing” is clinically significant, its relation to clinical outcomes is unknown. "Claims relating to efficacy and/or safety (e.g. duration of effect) must be based on evidence rather than being inferred from characteristics such as dosing frequency. For example, a TMA recommendation for “once daily dosing” does not necessarily equate to “24-hour efficacy”.”. To your question “Hence from my understanding, this is implying that when speaking of your own drug's dosage it is 'clinical' information, but when comparing dosage of products from multiple TMAs it constitutes 'non-clinical' information. Please help clarify”, note the part of the response that states: “Although an individual product’s indication and dosing info is clinically significant, the significance of the incremental difference in indication/dosing between multiple products is generally unknown”. One cannot infer clinical significance/outcomes to product features where none has been established.
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Hello @mhe
The entirety of the response highlights that while “dosing” is clinically significant, its relation to clinical outcomes is unknown. "Claims relating to efficacy and/or safety (e.g. duration of effect) must be based on evidence rather than being inferred from characteristics such as dosing frequency. For example, a TMA recommendation for “once daily dosing” does not necessarily equate to “24-hour efficacy”.”. To your question “Hence from my understanding, this is implying that when speaking of your own drug's dosage it is 'clinical' information, but when comparing dosage of products from multiple TMAs it constitutes 'non-clinical' information. Please help clarify”, note the part of the response that states: “Although an individual product’s indication and dosing info is clinically significant, the significance of the incremental difference in indication/dosing between multiple products is generally unknown”. One cannot infer clinical significance/outcomes to product features where none has been established.
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@jennifer-carroll Thanks. So if would the statement "convenient once daily dose" for example, be a clinical or non-clinical claim? For persecptive, speaking only of one's own drug and not relating to efficacy/safety/therapeutic claim.
Hey @mhe
The answer is nuanced and context driven. While dosing has clinical relevance for appropriate use of the product, the convenience of once daily dosing does not necessarily translate into a clinical outcome such as adherence, safety, and/or efficacy. As such, a claim of “convenient once-daily dosing” would not require a disclaimer of “Clinical significance unknown” but it would not be permissible to present it in a context that suggests unsubstantiated significance.
