@admin
Hi, we would like to get some clarity on the type of studies that this guidance document encompasses, specifically for:
• Extension study of pivotal trials that have a longer duration of follow-up than the one mentioned in the product monograph. In this case, the duration of use (# of cycles or # of years) of the drug is as per the recommended duration in the product monograph but the median follow-up is longer than the median follow-up mentioned in the product monograph, which include information on the primary and secondary outcomes data.
• Further, the extension study is published in a peer-review journal and was a pre-planned extension or subsequent interim/final analyses of randomized, controlled trials (RCTs).
With the appropriate balance and disclosures, would the above study be considered as reference support for advertising messages ?
Thank you in advance for your response.