599 - Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled data are not regarded as high-level evidence, but in some cases Health Canada has requested the pooling of data, not the study design itself.
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Many variables impact the specific answer to your situation. A couple of key considerations, for example, are whether the individual studies meet the rigors required by the PAAB code/guidances and whether the results of the individual study you want to present is in alignment with pooled outcome in the product monograph. Although pooled data is not generally regarded as being high-level of evidence, advertising must be consistent with the Terms of Market Authorization (i.e. product monograph) and certainly cannot contradict it. For an answer more specific to your situation, you’ll need to submit a written (see fee schedule on our site).
