BOIN: a novel Bayesian design platform to accelerate early phase brain tumor clinical trials.

ABSTRACT: Despite decades of extensive research, the progress in developing effective treatments for primary brain tumors lags behind that of other cancers, largely due to the unique challenges of brain tumors (eg, the blood-brain barrier and high heterogeneity) that limit the delivery and efficacy of many therapeutic agents. One way to address this issue is to employ novel trial designs to better optimize the treatment regimen (eg, dose and schedule) in early phase trials to improve the success rate of subsequent phase III trials. The objective of this article is to introduce Bayesian optimal interval (BOIN) designs as a novel platform to design various types of early phase brain tumor trials, including single-agent and combination regimen trials, trials with late-onset toxicities, and trials aimin

SUBMITTER: Yuan Y 

PROVIDER: S-EPMC8579094 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature