Phase I/II Design for Selecting Subgroup‐Specific Optimal Biological Doses for Prespecified Subgroups
Sydney Porter,
Thomas A. Murray,
Anne Eaton
Abstract:We propose a phase I/II trial design to support dose‐finding when the optimal biological dose (OBD) may differ in two prespecified patient subgroups. The proposed design uses a utility function to quantify efficacy‐toxicity trade‐offs, and a Bayesian model with spike and slab prior distributions for the subgroup effect on toxicity and efficacy to guide dosing and to facilitate identifying either subgroup‐specific OBDs or a common OBD depending on the resulting trial data. In a simulation study, we find the pro… Show more
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