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Abstract Details

Activity Number: 342
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305684
Title: Optimal Dose finding for Phase I Cancer Clinical Trials
Author(s): Shanhong Guan*+
Companies: Sanofi
Address: 300 Third Street, Cambridge, MA, 02142, United States
Keywords: Bayesian ; Clinical trials ; Dose finding ; Frequentist ; Oncology ; Phase I

The main purpose of a phase I trial of a new antitumor agent is to determine the appropriate dosing regimen and characterize the safety profile of a new anti-cancer treatment. In this paper, commonly used and more recently developed statistical designs, based on either frequentist approaches or Bayesian framework, for phase I cancer clinical trials are reviewed and discussed. Simulation studies are conducted to compare some of the novel designs against traditional approaches such as 3 + 3. Based on empirical numerical results, further discussion on advantages and shortcomings of these designs are provided and directions of designing more efficient phase I cancer trials are explored

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