Treatment allocation strategies for umbrella trials in the presence of multiple biomarkers: A comparison of methods.

ABSTRACT: Umbrella trials are an innovative trial design where different treatments are matched with subtypes of a disease, with the matching typically based on a set of biomarkers. Consequently, when patients can be positive for more than one biomarker, they may be eligible for multiple treatment arms. In practice, different approaches could be applied to allocate patients who are positive for multiple biomarkers to treatments. However, to date there has been little exploration of how these approaches compare statistically. We conduct a simulation study to compare five approaches to handling treatment allocation in the presence of multiple biomarkers - equal randomisation; randomisation with fixed probability of allocation to control; Bayesian adaptive randomisation (BAR); constrained randomisation

SUBMITTER: Ouma LO 

PROVIDER: S-EPMC7612600 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature