Question 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).

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