Bioequivalence and Bioavailability Forum • Could we design the RCT as a non-inferiority trial at this situation?

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

posted by ElMaestro – Denmark, 2022-07-26 12:44 (18 d 01:04 ago) – Posting: # 23178
Views: 327

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

Complete thread:

Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-24 17:39 [Design Issues]
- Non-Superiority Helmut 2022-07-25 16:37
  - Non-Superiority dennis001 2022-07-26 02:32
    - Non-Superiority Helmut 2022-07-26 15:04
      - Non-Superiority dennis001 2022-07-27 05:18
        
        Placebo effect Helmut 2022-07-27 12:17
- Could we design the RCT as a non-inferiority trial at this situation?ElMaestro 2022-07-26 12:44
  - Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-27 05:21