Sample Size for Non-Inferiority Tests for One Proportion: A Simulation Study

Abstract

The objective of non-inferiority trials is to demonstrate the efficiency of a novel treatment whether it is acceptably less or more efficient than a control or active (existing) treatment. They are employed in situations where, when compared to the active treatment, the novel treatment is to be advantageous with higher rates of reliability, compatibility, cost-efficiency, etc. Odds ratio is the most significant measure used in investigating the size of efficiency of treatments relative to one another. The purpose of the study is to calculate and evaluate the sample size under different scenarios based on three different test statistics in non-inferiority trials for one proportion via Monte Carlo simulations.