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 (428 d 14:48 ago) – Posting: # 23163
Views: 1,933

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
22,759 posts in 4,775 threads, 1,628 registered users;
21 visitors (0 registered, 21 guests [including 5 identified bots]).
Forum time: 10:28 CEST (Europe/Vienna)

Whenever a theory appears to you as the only possible one,
take this as a sign that you have neither understood the theory
nor the problem which it was intended to solve.    Karl R. Popper

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