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首页> 外文期刊>Journal of neurology >Disease-modifying therapy in MS: a critical review of the literaturePart I: Analysis of clinical trial errors.
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Disease-modifying therapy in MS: a critical review of the literaturePart I: Analysis of clinical trial errors.

机译:MS中的疾病缓解疗法:对文献的严格审查第一部分:临床试验错误的分析。

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摘要

Several types of errors are commonly made during the conduct, analysis, and interpretation of clinical trials in multiple sclerosis (MS). These include statistical errors of overestimating the significance of trial results, particularly when multiple endpoints are evaluated. They also include errors arising from the use of inappropriate covariate analyses, meta-analyses, and post hoc subgroup analyses. Interpretation of trial results can also be confounded by regression to the mean, by post hoc data re-analysis, and by the use of a non-concurrent control population. As these kinds of errors continue to plague the medical literature, it has become important for physicians to be able to assess critically the reports of clinical trial results. In turn, this has made it necessary for physicians to become familiar with the rudiments of the fields of statistics, epidemiology, and trial design. It is the purpose of this manuscript, therefore, to provide an overview of these principles through a detailed analysis of these kinds of clinical trial errors, together with examples that have actually occurred in the recently published MS literature.
机译:在进行,分析和解释多发性硬化症(MS)临床试验期间,通常会犯几种类型的错误。这些包括过高估计试验结果的重要性的统计错误,尤其是在评估多个终点时。它们还包括因使用不合适的协变量分析,荟萃分析和事后子组分析而引起的错误。还可以通过均值回归,事后数据重新分析以及使用非并行对照人群来混淆试验结果的解释。随着这些错误继续困扰着医学文献,对医生来说,能够严格评估临床试验结果的报告已变得很重要。反过来,这使得医师有必要熟悉统计学,流行病学和试验设计领域的基本知识。因此,本手稿的目的是通过对这些类型的临床试验错误以及最近在MS文献中实际发生的示例进行详细分析,以概述这些原理。

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