An adaptive noninferiority margin and sample size adjustment in covariate-adjustment regression model approach to noninferiority clinical trials
Lei Nie, Guoxing G Soon, William Tauber, Mohammad F. Huque · Model Assisted Statistics and Applications · 2010
The traditional fixed margin approach for evaluating an experimental treatment through an active-controlled noninferiority trial is simple and straightforward. However its utility is highly dependent on the ability of the experimental data to satisfy