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[Design principles and statistical considerations in oncological non-inferiority clinical trials]
1Department of Epidemiology and Health Statistics, School of Public Health, Xi'an Jiaotong University, Xi'an 710061, China.
None:
Non-inferiority clinical trials are a research paradigm that employs randomized controlled methods to evaluate whether the treatment effect of the experimental group is not inferior to that of the active control group within a predefined acceptable margin. This article systematically summarizes the applicable conditions, key design elements, and statistical analysis methods for non-inferiority trials. By integrating representative case studies in the field of oncology, it elucidates the unique value of non-inferiority designs in balancing benefits and risks and in optimizing therapeutic decisions. Through reviewing theoretical frameworks and addressing common misconceptions in methodological practices, this study aims to provide clear guidance for the standardized design and scientific interpretation of non-inferiority trials, thereby promoting their high-quality application in clinical research.
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