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Abstract Details

Activity Number: 113
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304148
Title: Utility-Based Dose-Finding in Phase I-II Clinical Trials
Author(s): Peter Thall*+ and Hoang Q Nguyen
Companies: MD Anderson Cancer Center and MD Anderson Cancer Center
Address: 1400 Pressler St., Houston, TX, 77030-4009,
Keywords: Clinical trials ; Phase I clinical trial ; Bayesian design ; Dose finding ; Utility ; Cancer trials
Abstract:

In this talk I will discuss sequentially adaptive Bayesian methods for choosing the dose of an experimental therapy based on elicited utilities of a bivariate ordinal or binary (toxicity, efficacy) outcome. Subject to admissibility rules to control the risk of severe toxicity and exclude unpromising doses, patients are randomized adaptively among the doses having posterior mean utilities near the maximum. Saturated parametric models are assumed for the marginal dose-toxicity and dose-efficacy distributions, possibly requiring monotonicity in dose, and a copula is used to obtain a joint distribution. Prior means are computed from elicited outcome probabilities using a simulation-based method, with prior variances calibrated to control prior effective sample size. The method is illustrated by two phase I-II trials, of (1) radiation therapy for children with brain stem gliomas, and (2) a BRAF inhibitor given with tumor infiltrating lymphocytes for patients with advanced melanoma.


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