On Inclusion of Covariates in Model Based Dose Finding Clinical Trial Designs.

ABSTRACT: There is a growing number of Phase I dose-finding studies that use a model-based approach, such as the CRM or the EWOC method to estimate the dose-toxicity relationship. It is common to assume that all patients will have similar toxicity risk given the dose regardless of patients' individual characteristics. In many trials, however, some patients' covariates (e.g., a concomitant drug assigned by a clinician) might have an impact on the dose-toxicity relationship. In this work, motivated by a real trial, we evaluate an impact of taking into account (or omitting) some patients' covariates on the individual target dose recommendations and patients' safety in Phase I model-based dose-finding study. We investigate several variable penalisation criteria and found that, for continuous and binary

SUBMITTER: Ollier A 

PROVIDER: S-EPMC11758501 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature