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临床试验设计入门

A primer on clinical trial design.

作者信息

Ellimoottil Chad, Vijan Sandeep, Flanigan Robert C

机构信息

Loyola University Medical Center, Department of Urology, Maywood, IL.

Department of Internal Medicine, University of Michigan, Ann Arbor, MI.

出版信息

Urol Oncol. 2015 Mar;33(3):116-21. doi: 10.1016/j.urolonc.2014.12.014. Epub 2015 Jan 23.

Abstract

A well-designed and executed clinical trial is the gold standard of evidence-based medicine. It is important for readers to understand the rationale for the study design, identify common pitfalls, and scrutinize limitations. Herein, we present a brief overview of types of designs used for clinical trials and discuss the use of appropriate end points, the selection of study participants, randomization, sample size calculation, blinding, and analysis of data. Finally, we emphasize the importance of accurate and transparent reporting. Our goal is to provide a primer for practicing urologists to enhance their understanding of the clinical trial literature.

摘要

精心设计并执行的临床试验是循证医学的金标准。对于读者来说,理解研究设计的基本原理、识别常见陷阱并仔细审查局限性非常重要。在此,我们简要概述临床试验中使用的设计类型,并讨论适当终点的使用、研究参与者的选择、随机化、样本量计算、盲法和数据分析。最后,我们强调准确和透明报告的重要性。我们的目标是为执业泌尿科医生提供一份入门指南,以增强他们对临床试验文献的理解。

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