医疗器械非劣效设计临床试验界值设定的现状与分析

Current Status and Analysis of Noninferiority Margin Setting in Clinical Trials for Medical Devices

本文选取了近20年来在《新英格兰医学杂志》(NEJM)、《柳叶刀》(Lancet)和《美国医学会杂志》(JAMA)三大医学期刊上发表的83项医疗器械非劣效设计临床试验,介绍和分析了非劣效界值设定现状。建议采用简捷的阳性对照预期值百分比方法设定非劣效界值,且界值百分比不宜超过50%,特别是当对照组预期值大于10%时,否则需要提供充分的理由。

This paper examines 83 medical device noninferiority clinical trials published in the New England Journal of Medicine,the Lancet,and Journal of the American Medical Association over the past 20 years.It introduces and analyzes the current status of noninferiority margin setting.The paper recommends a straightforward way of setting the noninferiority margin using a percentage of the positive control group’s expectation,with the percent margin not exceeding 50%.This is especially crucial when the expectation in the control group is greater than 10%,and if exceeded,there should be sufficient justification.