285 - Hi, I have a study (contained in the PM) in which only 2 versions of the same drug are being compared. The PM contains baseline and last visit levels of an endpoint marker for both drugs. In a branded detail aid, am I allowed to show a graph (baseline vs. last visit) for just one of the drugs? Or do I have to show the same type of baseline vs. last visit graph for both drugs? Thanks!

  • This type of question is best answered during the review or prior to it in the context of an opinion submission. In general, the efficacy results of a controlled trial are only interpretable in the context of both the treatment arm and the control arm (along with the corresponding statistical significance). Based on the limited info I have about your scenario, I'd have to advise reflect the PM (i.e. show both versions with the corresponding stats).