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Activity Number: 322
Type: Contributed
Date/Time: Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #305497
Title: Comparing CRM with Frequentist t-Statistic Method for Phase I Clinical Trials in Oncology
Author(s): Amit Phansalkar*+
Companies: Cytel, Inc.
Address: 675 Massachusetts ave, Cambridge , MA, 02139,
Keywords: adaptive ; CRM ; Bayesian ; frequentist ; oncology ; simulation
Abstract:

There are several ways to design and analyze Phase I clinical trials in oncology where the primary objective is to estimate the maximum tolerated dose (MTD). We will describe results from simulation experiments that compare the traditional 3+3 design, the Bayesian Continual reassessment method (CRM) design and a frequentist t-statistic method of Ivanova, Bolognese et. al.(2008). The CRM design implemented here includes extensions that use the power model to estimate the posterior probability of response at each dose level. The methods will be compared using data generated from a series of dose-response curves reflecting high early response as well as late rising mean response and the null case. Effectiveness of the methods will be examined along the dimensions such as power, probability of selecting MTD at the target dose, the expected sample size and the probability of stopping early.


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