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Activity Number: 342
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305632
Title: Posterior Probability of Adverse Events (AE) Categories for Phase I Studies
Author(s): Kyounghwa Bae and John W. Seaman III, PhD and Mark VonTress*+
Companies: Alcon Laboratories and Alcon Laboratories and Alcon Laboratories
Address: 6201 S. Freeway TC-41, Fort Worth, TX, 76134,
Keywords: Phase I ; Bayesian ; Advers Events

Phase I trials are often utilized to find the maximum tolerated dose (MTD) of a treatment with a dose-limiting toxicity (DLT) no more than some pre-determined rate. In the Bayesian setting, the posterior distribution for the probabilities of a DLT is used to choose a dose for the next patient cohort using information that has been collected in the trial. Neuenschwander et al. (2008) used a Bayesian approach to summarize and categorize the posterior probability of a DLT after each patient cohort which allows for the incorporation of uncertainty, rather than using a point estimate. We use this concept in a logistic regression, as its parameters can be understood intuitively by a non-statistician. This modified method calculates a posterior probability of adverse event categories and also determines the MTD using the Escalation With Over dose Control method (2010). A user friendly R program for the modified method has been developed.

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