复杂组序设计软件

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-30 DOI:10.1016/j.cct.2025.107994

Yujie Zhao, Keaven Anderson

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引用次数: 0

摘要

组序设计（GSD）是临床试验中采用的一种统计方法，可以根据累积的数据进行中期分析（IA）和潜在的早期终止。它在临床试验领域获得了显著的普及，因为它能够提高决策和加快有效治疗的发展。近年来，GSD的实施变得越来越复杂。例如，在最近的几次试验中，治疗效果可能会随着时间和阶层而变化。考虑到GSD的复杂性，拥有适当的软件来促进必要的计算是至关重要的。本文将使用示例和模拟来介绍用于GSD的R包，特别是gsDesign2和simtrial。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Software for complex group sequential designs

Group sequential design (GSD) is a statistical methodology employed in clinical trials to enable interim analyses (IA) and potential early termination based on accumulating data. It has gained significant popularity in the field of clinical trials due to its ability to enhance decision-making and expedite the development of effective treatments. The implementation of GSD has grown progressively intricate in recent times. For instance, in several recent trials, the treatment effect may vary over both time and strata. Given the complexity of GSD, it is crucial to have appropriate software that facilitates the necessary calculations. This article will introduce R packages for GSD using both examples and simulations, notably gsDesign2 and simtrial.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.