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Activity Number:
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404
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Type:
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Contributed
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Date/Time:
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Wednesday, August 6, 2008 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301763 |
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Title:
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Bayesian Sample Size Determination for Confirmatory Trial
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Author(s):
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Qin Pan*+ and Charles DuMond
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Companies:
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ICON Clinical Research and ICON Clinical Research
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Address:
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555 Twin Dolphin Drive, Redwood city, CA, 94065,
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Keywords:
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confirmatory trial ; power prior ; sample size determination
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Abstract:
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Oncology trial often need take long time to get the result due to the competition, small patient population and long follow up time when the primary end point is time to event. FDA usually required confirmatory trial to approve a drug. We explore the application of design the second trial using Bayesian power prior method that presented by Santis(2007) to do sample size determination based on first trial result. Comparison will be made to the sample size for the second trial by using the full weight given to the prior trial result, discount weight to prior trial result, and classical frequency approach. The hypothetic confirmatory study design will use simulated data.
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