Design principles and statistical considerations in oncological non-inferiority clinical trials
10.3760/cma.j.cn112152-20250304-00086
- VernacularTitle:肿瘤非劣效性临床试验的设计原则与统计分析要点
- Author:
Yamei LIU
1
;
Tao CHEN
;
Yang WANG
;
Chao LI
Author Information
1. 西安交通大学医学部公共卫生学院流行病与卫生统计学系，西安710061
- Publication Type:Journal Article
- Keywords:
Neoplasms;
Non-inferiority trial;
Randomized controlled trial;
Research design;
Margin
- From:
Chinese Journal of Oncology
2025;47(10):991-1000
- CountryChina
- Language:Chinese
-
Abstract:
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.
