Module 9 2021

22/03/2021

EQUIVALENCE OF EFFICACY USUALLY NEEDS TO BE ESTABLISHED IN CLINICAL TRIALS IN PATIENTS

Equivalence trials are fraught with difficulties. Can’t demonstrate equivalence with 100% certainty Even 2 identical products, give differences in trial results due to chance because of inherent variation within the population. Not realistically possible to show with reasonable certainty (95% confidence), preservation of much more than 50% of the therapeutic effect of the reference product.

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ENSURING ASSAY SENSITIVITY

Equivalence trial needs to be carried out in a setting in which the RP is known to work and in which the magnitude of effect is known. Thus an equivalence trial needs to be based on an historic reference trial in which the RP has been compared against placebo. The therapeutic equivalence trial therefore needs to recruit a similar population who are treated in a similar way to those in the reference trial .

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