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 (690 d 21:17 ago) – Posting: # 23163
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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!

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