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对数据进行恰当的分析和呈现是良好临床实践的必备条件。

Appropriate analysis and presentation of data is a must for good clinical practice.

作者信息

Hayran M

机构信息

OMEGA Contract Research Organization, Ankara, Turkey.

出版信息

Acta Neurochir Suppl. 2002;83:121-5. doi: 10.1007/978-3-7091-6743-4_20.

Abstract

Good Clinical Practice (GCP) is defined as an international ethical and scientific quality standard for designing, conducting, monitoring, auditing, analyzing and reporting trials that involve the participation of human subjects. This paper focuses mainly on the issues that need attention at the time of statistical analysis and reporting of results. Findings from a review of published articles in Turkey are also presented. The types of variables, the distributions of variables, the number of groups compared, the dependency structure among these groups and the primary goal of the analysis determine the appropriate method to be selected for the statistical analysis. The review of a stratified sample of research articles from 60 journals published in 1992 in Turkey revealed that in 56% of the cases the statistical methods were improper or inadequate. In 15% of the articles the authors failed to select an appropriate design for the proposed aim mentioned in the manuscript. Despite the recent improvements, the necessity and the value of performing and presenting research according to the international standards remains to be assimilated better by Turkish investigators.

摘要

《药物临床试验质量管理规范》(GCP)被定义为一项国际伦理和科学质量标准,用于设计、开展、监查、稽查、分析和报告涉及人类受试者参与的试验。本文主要关注统计分析和结果报告时需要注意的问题。还展示了对土耳其已发表文章的综述结果。变量的类型、变量的分布、比较的组数、这些组之间的依存结构以及分析的主要目标决定了为统计分析选择的合适方法。对1992年在土耳其出版的60种期刊上的研究文章分层抽样综述显示,56%的案例中统计方法不当或不充分。15%的文章中作者未能为稿件中提出的目标选择合适的设计。尽管最近有所改进,但土耳其研究人员对按照国际标准开展和呈现研究的必要性和价值仍有待更好地领会。

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