Hello, Is it possible to do an ad based on a peer review randomized Head to Head clinical trial that compares our Drug A with Drug B (both approved by HC for this indication). This clinical trial demonstrated superiority of Drug A vs Drug B. Our PM does not provide information about superiority against this drug (pivotal studies did not compare against this drug), however, we have comparison using the same endpoint against placebo. Is it possible to claim superiority in this case?
Jennifer Carroll last edited by
Evidence not presented in the TMA can be considered in pieces when it is consistent with the TMA and supported by statistically significant, high quality data of predefined study endpoints from a published and peer-reviewed randomized control trial (s.5.9). You have correctly identified some key features we look for (i.e. same indication, consistency with outcome type) along with other things such as comparable dosage strengths or blinding. A key document on the PAAB website which can further assist you in assessing the potential acceptability of the study and claims you wish to make the Marketing benefit claims: what are they and what level of support do they require document. You may also want to check out Subjective versus Objective Endpoints and Guidance on Non-inferiority Trials which speak to consistency with the TMA.