title: Another point of view: superiority, noninferiority, and the role of active comparators.
abstract: Despite substantial agreement with points made by Andrew C. Leon, PhD, in his article, I am not in complete agreement in a few areas. The definition of noninferiority proposed by Leon allows drugs somewhat less effective than placebo to be characterized as noninferior to placebo, and 2 active drugs may each be simultaneously noninferior to the other. Moreover, including a placebo arm in comparing 2 active drugs is of no use in deciding whether the study is well designed or not, since a significant difference between one of the active arms and the placebo may be due to chance or to a bias in the design. An alternative view of the situation is presented.
authors.forename: Helena Chmura
authors.initials: HC
authors.lastname: Kraemer
mesh_terms: D057186:Comparative Effectiveness Research / Q000592:standards*; D006801:Humans; D011570:Psychiatry / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*