The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
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636 - Can a claim of "Proven efficacy" appear over a presentation of clinical data, if that data was the basis for the product indication?
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When clinical trial data is presented in advertising it should be clear that the results are based on past study findings. The data should not be presented in a manner which suggests that the results can be expected, or extrapolated beyond the study setting. This applies to all data presentations, including data that Health Canada reviewed as the basis for the product indication. By positioning the term “Proven efficacy” above clinical data it suggests that the results are guaranteed and can be expected by all patients. This would not be accepted over any type of clinical trial data.
