## Could we design the RCT as a non-inferiority trial at this situation? [Design Issues]

Hi dennis001

❝ So, could we design the RCT as a non-inferiority trial?

Clearly a case for an NI trial one way or another.

❝ Moreover, how to defining the non-inferiority margin at the situation?

Clearly a case for a scientific advice where you need the authority's nod for margin and design before you kick off.

Pass or fail!
ElMaestro