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Activity Number:
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54
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
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Sponsor:
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Biometrics Section
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| Abstract - #304329 |
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Title:
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Theoretical and Practical Application of Traditional and Accelerated Titration (AT) Phase I Clinical Trial Designs: The Wayne State University Experience
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Author(s):
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Elisabeth I. Heath and Patricia M. LoRusso and S. Percy Ivy and Larry Rubinstein and Michaele C. Christian and Lance K. Heilbrun*+
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Companies:
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Karmanos Cancer Institute and Karmanos Cancer Institute and National Cancer Institute and National Cancer Institute and National Cancer Institute and Karmanos Cancer Institute
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Address:
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Biostatistics Unit, 716 HPOB, Detroit, MI, 48201,
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Keywords:
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Phase I trial designs ; accelerated titration
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Abstract:
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We report our center's experience in evaluating novel agents using both Traditional and AT types of Phase I trial designs over a 13-year period. Results from 9 Phase I clinical trials of multiple cytotoxic agents conducted at Wayne State University/Karmanos Cancer Institute in Detroit, MI and published from 1995--2005 were analyzed for this report. The mean number of patients treated on four Phase I trials using the Traditional Phase I trial design was 34 compared to a mean of 23.8 patients treated on five Phase I trials using the AT design. The mean length of study time (25-26 months) was similar in both trial designs. The theoretical advantages and disadvantages of both Phase I trial designs did not readily emerge in their actual application in clinical trials conducted at our institution.
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