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 dennis001 – Hong Kong, 2022-07-24 19:39 (904 d 05:16 ago) – Posting: # 23163
Views: 4,108

Dear all,

We plan to conduct a randomized controlled trial.
The goal of an RCT is to compare the difference of complication rates of CVD surgery between two groups (group A and group B).
The patients in group A will take medicine (traditionally treatment) and the patients in group B without taking medicine.

Notably, we want to design the RCT as a non-inferiority trial. That is, the effect of complication rates of patients without taking medicine in group B is not worse than the patients in group A with take medicine.

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

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

Thanks a lot!

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