Non-inferiority Sample Size Estimation [Power / Sample Size]
Anyone know about the sample size estimation for the non inferiority clinical trials, as per the literatures and some google says to consider the NI Margin to some percentage and estimate the sample size
I have tried to do the same in FARTSSIE23 (Non-inferiority, Parallel), but in addition to that Standard deviation is necessary for the same and in SAS (PROC POWER), we need to provide the CV to estimate the sample size
Can we assume the standard deviation or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?
Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?
Edit: Category changed; see also this post #1. [Helmut]