This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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18
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306419 |
Title:
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Novel Phase I Design for Oncology Research
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Author(s):
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Linda Sun*+ and Keaven M. Anderson and Lisa Lupinacci and Yevgen Tymofyeyev
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Companies:
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Merck & Co., Inc. and Merck Research Laboratories and Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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, , PA, 19446, USA
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Keywords:
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Phase I oncology ;
Bayesian ;
Adaptive
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Abstract:
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The primary objective of Phase I oncology studies is to identify a dose with an acceptable toxicity rate to move into Phase II efficacy studies. Various Phase I oncology designs have been proposed in the past, from the simplest 3+3 design to the more complex continuous reassessment method (CRM). In this talk, we will introduce an easy-to-implement Bayesian adaptive design which makes dose escalation or de-escalation based on the posterior probability of the toxicity rate at the dose level currently being tested. Simulation results show that this novel design out-performs the 3+3 design with higher probability of choosing the dose with the targeted toxicity rate. It slightly under-performs the CRM design. However, this design can show the dose escalation rules in a simple table before the study starts. This feature is very appealing to physician, regulatory reviewers, and IRBs.
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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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