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Activity Number: 278
Type: Invited
Date/Time: Tuesday, August 5, 2008 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #300952
Title: Dose-Finding in Phase I Clinical Trials Based on Toxicity Probability Intervals
Author(s): Yuan Ji*+
Companies: The University of Texas M.D. Anderson Cancer Center
Address: 1515 Holcombe Blvd., Houston, TX, 77030,
Keywords: Dose escalation ; Dose de-escalation ; MTD ; Trial monitoring ; Bayesian design
Abstract:

Most phase I clinical trials conducted at the M. D. Anderson Cancer Center use the algorithmic 3+3 design, despite the availability of more advanced model-based designs such as the continual reassessment method. Through simple statistical modeling and computing, we develop a dose-finding design that can be easily understood and implemented by nonstatisticians. We propose a beta/binomial Bayesian model and a probabilistic up-and-down rule that allow all possible dose-assignment actions to be tabulated in a spreadsheet. We have developed an Excel macro (available at http://odin.mdacc.tmc.edu/~yuanj/software.htm) that generates trial monitoring tables, which contain the dose-assignment actions corresponding to various toxicity outcomes. The new design outperforms the 3+3 design and performs comparably to other model-based methods in the literature.


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Revised September, 2008