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Activity Number:
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105
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308854 |
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Title:
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A Two-Stage Multinomial Randomized Selection Design in Phase II Oncology Trials
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Author(s):
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Zhiping Sun*+
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Companies:
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Merck & Co., Inc.
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Address:
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1258 Jarvis Ln, Lansdale, PA, 19446,
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Keywords:
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Randomized selection design ; multinomial ; two-stage
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Abstract:
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The objective of a phase II study in oncology is to evaluate whether an agent, at the doses determined by phase I trials, is worth of further investigation in phase III. Since several maximum tolerated doses corresponding to different dosing schedules may arise from phase I trials, a randomized selection design in phase II is more popular than a single arm design. Because progression-free rate is more related to the clinical endpoint(s) in phase III, a phase II design based on multiple outcomes is more reliable than a design based on the single conventional endpoint response rate. These concerns motivate the proposal and application of a two-stage randomized multinomial selection design in phase II oncology trials.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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