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Abstract Details

Activity Number: 522
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306689
Title: Evaluating Oncology Phase II Study Designs
Author(s): Zhuying Huang*+ and Hui Liu and Lindsey Lian
Companies: PPD and PPD and PPD
Address: 7551 Metro Center Drive, Suite 300, Austin, TX, 78744, United States
Keywords: Oncology ; Phase II ; Study Design

Phase II oncology study has its own challenges, in terms of minimizing number of subjects receiving non-efficacious treatment and achieving its objectives with the least number of subjects involved possible. To address the challenges, quite a few design approaches have been developed, for example, Simon two-stage design, two-stage Bayesian design, adaptive two-stage design, etc. Depending on the objectives and limits of a specific trial, different design method may fit the needs better. By using simulated data that mimic results from actual Oncology Phase II studies, we evaluate each design against different clinical trial setting. Suggestions on best design fitting each setting are provided.

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