Module 9 2021

22/03/2021

THERAPEUTIC EQUIVALENCE

51

CLINICAL TRIAL DATA: FDA VS. EU

US

EU

Trial Population Endpoints

Most sensitive – but views on this can differ

Views may differ

Risk Ratio

Proportions

Equivalence margin

Preserve >50% effect

> Putative placebo effect

90% CI

95%CI

Switching May be required

Discouraged 12 months

Study duration

12 months

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