Enhancing phase I dose-finding trials design through dynamic borrowing information and handling late-onset toxicity.

ABSTRACT: Introduction: In recent years, there has been a growing trend among regulatory agencies to consider the use of historical controls in clinical trials as a means of improving the efficiency of trial design. In this paper, to enhance the statistical operating characteristic of Phase I dose-finding trials, we propose a novel model-assisted design method named "MEM-Keyboard". Methods: The proposed design is based on the multisource exchangeability models (MEMs) that allows for dynamic borrowing of information from multiple supplemental data sources, including historical trial data, to inform the dose-escalation process. Furthermore, with the frequent occurrence of delayed toxicity in novel anti-cancer drugs, we extended our proposed method to handle late-onset toxicity by incorpo

SUBMITTER: Yang W 

PROVIDER: S-EPMC10703472 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature