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Abstract Details
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Activity Number:
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423
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Type:
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Contributed
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Date/Time:
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Tuesday, August 2, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302791 |
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Title:
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Evaluating Oncology Phase I Dose-Finding Study Designs
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Author(s):
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Lindsey Lian and Hui Liu*+ and Jenny Huang
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Companies:
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PPD and PPD and PPD
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Address:
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, , 78744, U.S.
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Keywords:
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study design ;
oncology ;
dose finding
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Abstract:
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The 3 + 3 design is still commonly used in oncology Phase I dose finding studies bearing its well known criticisms. To overcome the criticisms, alternative design methods have been proposed, including but not limited to modified continual reassessment method (MCRM) and escalation with overdose control (EWOC). 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 I studies, we evaluate each design (3+3, MCRM, EWOC, etc) against different clinical trial setting, e.g. when duration/sample size of a trial is set, when trial subject safety/efficacy is of the most concern, when selecting the right phase II/III dose is the main goal, etc. Suggestions on best design fitting each setting are provided.
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Authors who are presenting talks have a * after their name.
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