Abstract

The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm parallel design was proposed to solve this problem. The purpose of this article was to extend the previous results to the time-to-event endpoints in the exponential model, the Cox proportional hazard model, and the restricted mean survival time. The relative distance is defined, and the corresponding test procedures are developed based on asymptotic theory. The Type I error rates and powers are investigated theoretically and empirically. Supplementary materials for this article are available online.

摘要

通常用于评估生物相似性的两臂平行设计的缺点是，它没有考虑参考产品内在的可变性。提出了三臂并联设计来解决这个问题。本文的目的是将先前的结果扩展到指数模型，Cox比例风险模型和受限平均生存时间中的事件到达时间终点。定义了相对距离，并根据渐近理论制定了相应的测试程序。从理论和经验上对I型错误率和功效进行了研究。可在线获得本文的补充材料。