430 - One of the pivotal trials for an advertised brand has a reference comparator (RC) arm (i.e., the trial has statistical analysis for the advertised brand vs placebo and the RC vs placebo, but no statistical analysis for the advertised brand vs RC). The Product Monograph mentions the RC as part of the design, but no RC data is included in the PM. Can the data for the RC vs placebo be shown in an APS?
Jennifer Carroll last edited by
No. An APS presentation conveying how the sponsor’s drug compares to a reference comparator would not meet the evidentiary requirements of the PAAB code (i.e. a rigorously designed study with pre-planned inferential statistical significance analysis directly comparing the two active products). Note however that the RC data could be considered in cases where the PM contains the RC data (rather than the only mention of the RC being in the study description). In such cases, the data presentation should reflect the context and emphasis of the product monograph.