equivalence trial

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equivalence trial2016-12-12T20:21:26+00:00

equivalence trial


A clinical trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically insignificant.

This is usually demonstrated by showing that the true treatment difference lies between a lower and an upper equivalence margin of clinically acceptable differences. Equivalence trial are intended to circumvent the ethical dilemmas of comparing a new therapy to a placebo–which is known to be less effective than a proven therapy, by running the new agent against a standard therapy. Equivalence trials are of use if a new therapeutic modality is deemed to be easier to use, have fewer side effects, or is less costly; equivalence to the standard assumes that the new therapy is better than a placebo.    

Reference NEJM 1997; 337:1118
Mod Drug Discovery 7,8/99, p31

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