A Narrative Review of Two-Arm and Three-Arm Non-Inferiority Clinical Trials

Abstract

Clinical trial is a research conducted to test the effectiveness and safety of the experimental drugs or treatments or diagnostic tools before approval using consenting human subjects as sample size. Non-inferiority test in clinical trial is performed to demonstrate that the experimental treatment is not worse than the reference treatment by more than a pre-defined margin. This type of design has accumulated much attention from the researchers as it is viewed as an alternative to the existing superiority trials. However, issues in the design and analysis of non-inferiority trials are still at large and highly debatable. Thus, the object of this paper is to address the gap in the literature, by providing a concise, narrrative review of some selected papers related to non-inferiority trials. The review of 162 published papers indicates potential studies related to two-arm and three-arm non-inferiority trials, focusing on the implementation of Bayesian design and analysis.