Ontology highlight
ABSTRACT: Background
Combination therapies directed at multiple targets have potentially improved treatment effects for cancer patients. Compared to monotherapy, targeted combination therapy leads to an increasing number of subgroups and complicated biomarker-based efficacy profiles, making it more difficult for efficacy evaluation in clinical trials. Therefore, it is necessary to develop innovative clinical trial designs to explore the efficacy of targeted combination therapy in different subgroups and identify patients who are more likely to benefit from the investigational combination therapy.Methods
We propose a statistical tool called 'IBIS' to Identify BIomarker-based Subgroups and apply it to the enrichment design framework. The IBIS contains three main elements: subgroup divi
SUBMITTER: Chen X
PROVIDER: S-EPMC10026491 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature