What is the relevance of superiority margin/ clinically meaningful margin / least relevant margin in randomized control trial for sample size calculation?
Suraj Kapoor A superiority study seeks to distinguish between treatments. The first stage in the analysis is generally a statistical significance test to see whether the trial findings are compatible with the premise that there is no difference in the clinical impact of the two therapies.
While Cohen defined big, medium, and small effects as d=0.8, 0.5, and 0.2, respectively, an FDA rule of thumb states that an impact is large if it is greater than 0.8, small if it is less than 0.5, and moderate if it lies between those values.