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Activity Number:
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457
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biometrics Section
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| Abstract - #309219 |
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Title:
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An Application of the Time-to-Event Continual Reassessment Method: Dose Escalation in Patients with Lymphoma Undergoing Chemotherapy over an Extended Period
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Author(s):
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Ken Cheung*+
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Companies:
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Columbia University
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Address:
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722 West 168th Street Rm 641, New York, NY, 10032,
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Keywords:
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Late toxicity ; Cancer
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Abstract:
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Traditional phase I designs require each patient or small group of patients to be completely followed before the next patient or group is enrolled. In situations where chemotherapy is given over an extended period, this may result in trials of impractically long duration. To evade the timeliness issue in practice, the safety endpoint is often defined with respect to a short time period (28 days): it will underestimate the harm if toxicity tends to appear beyond the 28-day window. In the talk I first review the time-to-event continual reassessment method (TITE-CRM), which allows patients to be entered in a staggered fashion while utilizing observations up to the full follow-up period from each patient. In the second half, I summarize the outcomes of a recent lymphoma trial that adopts the TITE-CRM, and evaluate in retrospect the relative merits of the TITE-CRM and the standard method.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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