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PSI One Day Meeting: Bayesian Methods for Dose Finding and Biomarkers, Feb 2018: Bayesian methods for design and analysis of clinical trials assessing multiple treatments and biomarkers

28 February 2018

Response to treatments is often highly heterogeneous, especially ones that are targeted at specific biological pathways. The increasing availability of biomarkers and targeted treatments has led to the need for trial designs that efficiently test new treatments in biomarker-stratified patient subgroups. Often new treatments are targeted at a specific biomarker subgroup, but may in fact work in a narrower or broader set of patients. I will discuss Bayesian adaptive methodology for trials that have multiple treatments and biomarkers. 

The proposed design incorporates biological hypotheses about the links between treatments and biomarker subgroups, but allows alternative links to be formed during the trial. The statistical properties of the method compare well to alternative designs available. This design has been developed for trials in ovarian cancer and breast cancer and some methodology issues specific to each application will be discussed. These include the use of continuous biomarker information to allocate patients and adding in new treatments and biomarkers during the trial.

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