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Activity Number: 579 - 30 Years Journey of Bayesian Adaptive Designs: From Bayesian Monitoring to Dynamic Treatment Regime — in Honor of Dr. Peter Thall’s 70th Birthday
Type: Topic Contributed
Date/Time: Thursday, August 6, 2020 : 3:00 PM to 4:50 PM
Sponsor: Biopharmaceutical Section
Abstract #309729
Title: Subgroup-Specific Dose Finding in Phase I Clinical Trials Based on Time to Toxicity Allowing Adaptive Subgroup Combination
Author(s): Andrew Genius Chapple* and Peter F. Thall
Companies: LSUHSC and M.D. Anderson Cancer Center
Keywords: Bayesian Analysis; Clinical Trials; Dose Finding; Phase I Trials; Personalized Medicine

A Bayesian design is presented that does precision dose finding based on time to toxicity in a phase I clinical trial with two or more patient subgroups. The design, called Sub?TITE, makes sequentially adaptive subgroup?specific decisions while possibly combining subgroups that have similar estimated dose?toxicity curves. Decisions are based on posterior quantities computed under a logistic regression model for the probability of toxicity within a fixed follow?up period, as a function of dose and subgroup. Clustering priors are assumed for subgroup parameters, with latent subgroup combination variables included in the logistic model to allow different subgroups to be combined for dose finding if they are homogeneous. This framework can be used in trials where clinicians have identified patient subgroups but are not certain whether they will have different dose?toxicity curves. A simulation study shows that, when two or more subgroups are truly homogeneous but differ from other subgroups, the Sub?TITE design is substantially superior to either ignoring subgroups, running separate trials within all subgroups, or other proposed subgroup trials that borrow strength but do not cluster.

Authors who are presenting talks have a * after their name.

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