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Activity Number: 639
Type: Topic Contributed
Date/Time: Thursday, August 4, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #320132 View Presentation
Title: Optimal Design for Dose-Finding Study with Delayed Responses
Author(s): Min Yang and Tian Tian*
Companies: University of Illinois at Chicago and University of Illinois at Chicago
Keywords: Adaptive ; Phase I
Abstract:

Delayed response is not uncommon in Phase I clinical trials. We may not be able to observe the toxicity outcome before the next dose assignment. Waiting for each patient's outcome may result in unfeasibly long trial. Ignoring the unobserved data may underestimate the toxicity and would put patients in danger of overly toxic doses. A proper approach is to treat the unobserved responses as censored observations. While there is substantial optimality literature for Phase I clinical trials, those results mainly focus on the situation that there is no delayed response. Little is known how to choose an optimal/efficient design when delayed responses are presented. In this talk, we shall systematically develop a new framework to address this issue. Some efficient/robust designs will be derived under this framework.


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

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