Korean J Anesthesiol.  2024 Aug;77(4):423-431. 10.4097/kja.23534.

Key insights and challenges in noninferiority trials

• Hong B
• Lee DK

• KMID: 2559490
• DOI: http://doi.org/10.4097/kja.23534

Abstract

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials.

Keyword

Bias; Clinical trials; Noninferiority margin; Noninferiority report; Noninferiority test; Sample size; Trial design