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.
翻译:最近,平台试验作为耗时的古典双臂随机控制试验的可能补救办法,特别是在早期药物开发阶段,最近引起了许多关注。这一短篇说明了如何使用CohortPlat R 软件包模拟组群平台试验,其中每个组群由综合治疗和各自的单一治疗和护理标准组成。最终点总是假定是二元的。该软件包为平台试验轨迹以及治疗效果假想和决定规则提供了广泛的灵活性。作为一个特殊特征,该软件包提供了一种指定功能,可以同时高效地进行多个模拟,并以简洁的方式保存结果。提供了许多代码使用示例。