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Activity Number:
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473
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Type:
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Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305531 |
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Title:
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Statistical Properties of a Modified Accelerated Design for Phase I Cancer Clinical Trials
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Author(s):
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Weili He*+ and Jun Liu and Hui Quan
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Companies:
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Merck & Co., Inc. and Rutgers University and sanofi-aventis
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Address:
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1129 Blvd., Westfield, NJ, 07090,
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Keywords:
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standard algorithm-based design ; DLT ; MTD ; a+b design
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Abstract:
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In recent years, the accelerated design has been proposed as an improvement to the standard algorithm-based design (Storer 1989 and Simon et al. 1997). There may be situations under the proposed accelerated designs by Storer and Simon et al. in which the MTD may be declared with undesirable features. We propose a modified accelerated design. Lin and Shih (2001) studied several key statistical properties for the standard algorithm-based A+B design based on the exact mathematical derivation. In this paper, we derive similar key statistical properties for the accelerated design. Under certain design settings, the modified accelerated design requires fewer expected number of patients, hence less time---sometimes significantly less---to complete the study; however, it may incur a higher overall expected toxicity rate.
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