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Activity Number:
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493
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Type:
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Invited
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Date/Time:
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Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303155 |
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Title:
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Translation of Innovative Designs Into Cancer Phase I Trials
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Author(s):
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Andre Rogatko*+
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Companies:
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Cedars-Sinai Medical Center
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Address:
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147 S. Robertson Blvd. Suite 100, Los Angeles, CA, 90048,
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Keywords:
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dose-finding ; Bayesian adaptive designs ; up-and-down method ; cancer phase I trials ; Translation ; dose-escalation
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Abstract:
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We examined abstract records of cancer phase I trials from the Science Citation Index database between 1991--2006 and classified them into clinical (dose-finding trials) and statistical (methodological studies of dose-escalation designs). We then mapped these two sets by tracking which trials adopted new statistical designs.1235 clinical and 90 statistical papers were identified. Only 1.6% of the phase I cancer trials followed a design proposed in one of the statistical papers. These twenty clinical studies showed extensive lags between publication of the statistical paper and its translation into a clinical paper. These twenty clinical trials followed Bayesian adaptive designs. The remainder employed variations of the standard up-and-down method. A consequence of using less effective designs is that more patients are treated with doses outside the therapeutic window.
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