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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304253 |
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Title:
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The Impact of Bioavailability on the Continual Reassessment Method
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Author(s):
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Jessica E. Pruszynski*+ and Anna McGlothlin and John W. Seaman, II
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Companies:
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Baylor University and Eli Lilly and Company and Baylor University
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Address:
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One Bear Place #97140, Waco, TX, 76798-7140,
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Keywords:
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continual reassessment method ; Phase I ; dose escalation ; bioavailability ; Bayesian clinical trial design ; oncology
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Abstract:
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The continual reassessment method (CRM) is a Bayesian design often used in Phase I cancer clinical trials. It models the toxicity response of the patient as a function of administered dose using a model that is updated as data accrues. The CRM does not take into consideration the relationship between the toxicity response and the proportion of the administered drug that is absorbed by targeted tissue. Not accounting for this discrepancy can yield misleading conclusions about the maximum tolerated dose to be used in subsequent Phase II trials. We will examine, through simulation, the effect that disregarding the level of bioavailability has on the performance of the CRM.
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