A New Approach for Non-Inferiority Assessment Using MLR Test Under Cox's PH Model Setting

Music City Center 

We propose a maximum likelihood ratio test to assess non-inferiority of an experimental therapy compared with an active control therapy as measured by a failure-time. That is the primary objective. The new maximum likelihood ratio (MLR) test is developed under the Cox's proportional hazards (PH) model setting with multiple (0-1) dichotomous covariates. Hypotheses are stated in terms of treatment regression coefficient. We show that the logarithm of the likelihood ratio test statistic is approximately normally distributed.

Partial likelihhod

Observed information matrix

Lognormal distribution

Lindeberg's CLT 

Biopharmaceutical Section