Methodological standards for assessing therapeutic equivalence.
This paper reviews issues related to defining and demonstrating therapeutic equivalence. A set of guidelines are proposed to critically review clinical trials to determine whether there is sufficient evidence to conclude that an experimental therapy is therapeutically equivalent to a standard one. These guidelines include criteria for assessing whether imprecision pertaining to the measurement of outcomes impinges on the validity of an equivalence test.
Peel Health Department, Brampton, Ontario, Canada.
B
B
Kirshner
D002986:Clinical Trials as Topic / Q000379:methods*; D006287:Health Planning Guidelines; D006801:Humans; D013810:Therapeutic Equivalency