论文标题

队列:研究组合疗法的队列平台试验的模拟

CohortPlat: Simulation of cohort platform trials investigating combination therapies

论文作者

Meyer, Elias Laurin, Mesenbrink, Peter, Dunger-Baldauf, Cornelia, Glimm, Ekkehard, König, Franz

论文摘要

平台试验最近引起了很多关注,这是耗时的经典两臂随机对照试验的可能补救措施,尤其是在早期药物开发中。这篇简短的文章说明了如何使用队列R软件包模拟同类平台试验,每个同类群体都由组合处理以及各自的单层和护理标准组成。终点总是被认为是二进制的。该软件包在平台试验轨迹以及治疗效果方案和决策规则方面具有广泛的灵活性。作为一项特殊功能,该软件包提供了指定的功能,用于并行运行多个此类模拟,并以简洁的方式保存结果。提供了许多代码使用的插图。

Platform trials have gained a lot of attention recently as a possible remedy for time-consuming classical two-arm randomized controlled trials, especially in early phase drug development. This short article illustrates how to use the CohortPlat R package to simulate a cohort platform trial, where each cohort consists of a combination treatment and the respective monotherapies and standard-of-care. The endpoint is always assumed to be binary. The package offers extensive flexibility with respect to both platform trial trajectories, as well as treatment effect scenarios and decision rules. As a special feature, the package provides a designated function for running multiple such simulations efficiently in parallel and saving the results in a concise manner. Many illustrations of code usage are provided.

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