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 (132 d 17:36 ago) – Posting: # 23163
Views: 1,213

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
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
19 visitors (0 registered, 19 guests [including 6 identified bots]).
Forum time: 12:16 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5