期刊
CONTEMPORARY CLINICAL TRIALS
卷 98, 期 -, 页码 -出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2020.106126
关键词
Oncology; Bliss independence model; Phase 2/3 trial; Sample size estimation
Researchers have long sought to find combinations of cancer drugs that might achieve synergy. However, while observed in some preclinical tumor models, synergistic effects are rarely seen in clinical trials. In fact, growing evidence in clinical trial data shows that the treatment effect of most approved combination therapies can be largely explained by the independent drug action model at the patient level. Previous statistical research on drug combinations mainly centered on experimental designs for dose-finding followed by measure of combination efficacy. In this paper, we introduce the independent drug action model to those working in late stage clinical development, propose a new approach to predict the progression-free survival of combination therapies, and discuss its statistical implications for trial design and monitoring. The discussion is enriched with real data examples.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据