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Activity Number: 247 - Clinical Trial Design- 2
Type: Contributed
Date/Time: Monday, July 30, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330453 Presentation
Title: Bayesian Isotonic Optimal Dose Design for Phase I/II Clinical Trials with Ordered Groups
Author(s): Xiaoqiang Xue*
Keywords: Bayesian ; Isotonic algorithm; Phase I/II; dose toxicity and clinical response; ordered groups

In immunotherapy dose-finding trials the optimal dose is usually defined based on both toxicity and response because toxicity little or no toxicity is often observed. In these trials toxicity and response often require a longer follow-up time compared to trials with cytostatic agents. The rapid enrollment design has been proposed for dose-finding trials to find the maximum tolerated dose where the follow-up for toxicity is long and it is desirable to assign a patient to a dose of a new therapy as soon as the patient is enrolled. We extend the rapid enrollment design to immunotherapy trials to find the optimal dose. We describe how to apply the design in trials with ordered groups where the estimation of the optimal dose can be improved by using the assumed monotonicity of toxicity and response among groups.

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

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