696 - We have a study we would like to use to support a claim in a new tool. In this study “DRUG B” is used as an add-on to our product, whereas in our product monograph our indication is stated as an add-on to “DRUG B”. Would this be an issue?
Jennifer Carroll last edited by
The first step in assessing the acceptability of the study is to determine if it is consistent with the TMA. We would consider consistency with the indication/patient population studied, dosing, etc. As the indication specifies that the product is an add-on to drug B and it is not used in that fashion in the study, the study design does not appear to be consistent with the TMA. As this appears to be a specific question about a specific product and study, we suggest submitting the published study in an opinion file where we can assess the study design and consistency with TMA.