Module 9 2024

05/09/2024

Clinical Trial Data: US vs EU

US

EU

Trial Population

Most sensitive – but views on this can differ

Endpoints

Views may differ

Risk Ratio

Proportions

Preserve >50% effect

> Putative placebo effect

Equivalence margin

90% CI

95%CI

Switching

May be required

Discouraged

Study duration

12 months

12 months

The Organisation for Professionals in Regulatory Affairs

47

For large complex proteins (e.g. Mabs) comparative efficacy trial usually required.

⚫ 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.

The Organisation for Professionals in Regulatory Affairs

48

24