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 (192 d 01:02 ago) – Posting: # 23163
Views: 1,377

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:

UA Flag
 Admin contact
22,478 posts in 4,708 threads, 1,603 registered users;
19 visitors (0 registered, 19 guests [including 7 identified bots]).
Forum time: 19:42 CET (Europe/Vienna)

I think it is much more interesting to live with uncertainty
than to live with answers that might be wrong.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz