The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment

Gayet-Ageron Angele; Agoritsas Thomas; Rudaz Sandrine; Courvoisier Delphine; Perneger Thomas

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The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment

机译：临床试验中非劣效性边缘的选择受基线风险，主要结局类型和新治疗获益的驱动

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摘要

Objectives: To explore characteristics of clinical trials that influence the choice of the noninferiority margin (NIM) when planning the trial.

机译：目的：探讨在规划试验时影响非劣效性边缘（NIM）选择的临床试验特征。

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来源
《Journal of Clinical Epidemiology》 |2015年第10期|共8页
作者
Gayet-Ageron Angele; Agoritsas Thomas; Rudaz Sandrine; Courvoisier Delphine; Perneger Thomas;
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正文语种 eng
中图分类流行病学与防疫;
关键词
Noninferiority margin; Noninferiority study design; Clinical trial; Sample size; Randomized controlled trials; Primary outcome; Minimal clinically important difference;

机译：非劣效性边缘;非劣效性研究设计;临床试验;样本量;随机对照试验;主要结果;最小的临床重要差异;

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1. The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment [J] . Gayet-Ageron Angele, Agoritsas Thomas, Rudaz Sandrine, Journal of Clinical Epidemiology . 2015,第10期

机译：临床试验中非劣效性边缘的选择受基线风险，主要结局类型和新治疗获益的驱动
2. Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus: The ADVANCE Trial [J] . Rahman Faisal, McEvoy John W., Ohkuma Yoshiaki, Hypertension: An Official Journal of the American Heart Association . 2019,第6期

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3. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA ? ): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk [J] . Julio Rosenstock, Vlado Perkovic, John H. Alexander, Cardiovascular Diabetology . 2018,第1期

机译：LINAgliptin（CARMELINA？）进行心血管安全性和肾脏微血管结果研究的基本原理，设计和基线特征：一项针对2型糖尿病和高心脏肾脏风险患者的随机，双盲，安慰剂对照临床试验
4. Poster: Classifying primary outcomes in rheumatoid arthritis: Knowledge discovery from clinical trial metadata [C] . Yuanyuan Feng, Janeja Vandana P., Yesha Yelena, IEEE International Conference on Computational Advances in Bio and Medical Sciences . 2015

机译：海报：对类风湿关节炎的主要结局进行分类：从临床试验元数据中发现知识
5. Perceived benefits and risks of clinical pharmaceutical trials in Colombia. [D] . Cordoba Pachon, Clara Ximena. 2010

机译：哥伦比亚临床药物试验的预期收益和风险。
6. Rationale design and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized double-blind placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk [O] . Julio Rosenstock, Vlado Perkovic, John H. Alexander, 2018

机译：LINAgliptin（CARMELINA®）进行的心血管安全性和肾脏微血管结果研究的基本原理设计和基线特征：一项针对2型糖尿病和高心脏肾脏风险患者的随机双盲安慰剂对照临床试验
7. Choice of treatment-effect measures when noninferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials [O] . Xianmixikemaier Abulizi, Philippe Flandre 2018

机译：选择效应措施的选择，当非敏感性边缘最初定义为相对差异的绝对差异影响临床试验结果

The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment

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