An efficient test based on the inferential model for the non-inferiority of odds ratio in matched-pairs design.

Non-inferiority of one treatment to another based on odds ratio for the matched-pair design is a common issue in the medical research. Liu et al. derived two asymptotic tests, delta method and score test, which can be applicable for large samples but may tend to be liberal for small sample sizes. Jin et al. proposed an IM-based method that can control the type I risk well but may be somewhat conservative. In this paper, we extend the IM-based method to RIM-based test using the randomized plausibility function. We prove that our new proposed method is not only valid but also efficient. Simulation studies confirm that the RIM-based test is better than other methods. A numerical example illustrates the proposed method.