PAAB Code 3.2.3
-
Reference to research or ongoing studies may be made in a non- promotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, which has been completed, has undergone an interim analysis, or has been presented at a medical meeting, and incorporates information that is not included in the Health Canada TMA, must not be mentioned in advertising.
In the Oncology space, one drug can, overtime, get studied in other completely different diseases (or tumour sites). If a TMA exists for disease A and is currently being studied in disease Z (completely unrelated), are the studies considered off-label or pre-NOC (not yet authorized by Health Canada)? I feel it is the latter given that it is a distinct disease (and indication) but wanted to double check
-
Hey @georgian21
The study is off-label as the product does not have NOC for the disease being investigated. -
@jennifer-carroll
Thanks Jennifer. Given that the product is not yet authorized for the indication being studied(pre-NOC) AND the studies are still ongoing, could we not create an APS that refers to these ongoing studies? Eg. Objective, Design, number of patients etc. The code seems to state this. -
Hello @Lags
The question above was interpreted as requesting clarification of the regulatory classification of the studies. While it did not specifically state that disease Z study was “ongoing” (the definition of this is critical – see below) , there are scenarios where an ongoing off-label study may be presented in APS, as well as scenarios where it must not be mentioned in APS. For further details of the discussion of ongoing studies, please see Code section 3.2.3 as well as Q&A 223 & Q&A 537
If the studies no longer qualify as ongoing (no longer in the data gather phase, or an interim analysis has been performed, data has been presented, etc.), the study cannot be discussed as it is considered off-label. There should be no pre-NOC advertising or off-label advertising. The crux of 3.2.3 is that it is non-promotional and intended only to outline the research the company is involved in.
