674 - Is it acceptable to compare the clinical trial inclusion/exclusion criteria among competitor products? We would like to make the point that patients with certain conditions were included in the trials for 1 product but not in trials for its competitors. I understand non-clinical information can be compared across products, and we wondered if inclusion/exclusion info was considered clinical or non-clinical. Could this be done in a branded context?

  • No. Clinical trials are conducted to measure efficacy and safety. The described presentation would imply an indirect cross-product comparison of the populations in which efficacy / safety was demonstrated. This would contravene section 5.7 of the PAAB code.