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Activity Number:
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137
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2016 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318868
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View Presentation
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Title:
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The Rapid Enrollment Design for Phase I Clinical Trials
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Author(s):
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Yunfei Wang*
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Companies:
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Children's National
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Keywords:
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Phase I trial ;
mTPI ;
RED ;
CRM ;
TITE-CRM
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Abstract:
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We propose a dose-finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose-toxicity curve is non-decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow-up. We also recommend using a safety rule with any dose-finding method.
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Authors who are presenting talks have a * after their name.
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