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SeminÃrio PIPGEs - UFSCar/USP - 14/06/2013 - 14h00 - no ICMC-USP



SeminÃrio PIPGEs - UFSCar/USP Â 14/06/2013 - 14h00
 

LOCAL: Sala 3-012 Â ICMC-USP

 

TÃTULO: Designing a Cancer Dose Finding Trial using EWOC

 

NOME: Andrà Rogatko - Samuel Oschin Comprehensive Cancer Institute - USA

 

RESUMO:

Escalation with overdose control (EWOC) is a Bayesian adaptive dose finding design that produces consistent sequences of doses while controlling the probability that patients are overdosed. EWOC was the first dose-finding procedure to directly incorporate the ethical constraint of minimizing the chance of treating patients at unacceptably high doses. Its defining property is that the expected proportion of patients treated at doses above the maximum tolerated dose (MTD) is equal to a specified value Î, the feasibility bound. Among designs with this defining property, EWOC minimizes the average amount by which patients are underdosed. This means that EWOC approaches the MTD as rapidly as possible, while keeping the expected proportion of patients overdosed less than the value Î. As a Trial progresses, the dose sequence defined by EWOC approaches the MTD (i.e., the sequence of recommended doses converges in probability to the MTD). Eventually, all patients beyond a certain time would be treated at doses sufficiently close to the MTD. Step-by-step instructions on how to design a trial using EWOC will be discussed using the web application that can be accessed at
http://biostatistics.csmc.edu/ewoc/. They include: Selecting Values for each Parameter, Adjusting the Dose Escalation, Design Operating Characteristics, and Creating a Dose Finding Protocol.