Efficacy Data

[GMC]

Can we present non-significant (N/S) efficacy data in an APS that is included in the Product Monograph (Part II: Clinical trials section)? Does it matter if it’s a primary, secondary or exploratory endpoint? If we can present N/S efficacy data, what parameters are required in order to present these in an APS?

[Jennifer Carroll]

Good morning @gmc

Similar to Q&A 332, p=ns data from the PM clinical trials section may be included in advertising providing there are no conclusions or claims that extend beyond that found in the PM. This is possible regardless of whether it is primary, secondary or exploratory.