This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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626
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Type:
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Contributed
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Date/Time:
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Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307428 |
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Title:
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Adaptive Sample Size Re-Estimation in Oncology Trials
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Author(s):
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Pralay Mukhopadhyay*+
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Companies:
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Bristol-Myers Squibb
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Address:
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5 Research Pkwy, P.O. Box 5100, Wallingford, CT, 06492,
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Keywords:
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Sample size re-estimation ;
CHW method ;
Survival analysis ;
Oncology trials
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Abstract:
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Phase III oncology trials are often designed with progression free survival (PFS) or overall survival (OS) as the primary endpoint. These trials are generally large and may take several years to complete. Traditional group sequential designs allow for early stopping due to benefit or futility. However they do not allow for adaptation based on treatment effect observed at the interim. Here the Cui-Hung and Wang (CHW) method for sample size readjustment has been evaluated for survival trials. A practical example and simulations are used to discuss pros and cons of the adaptive design. Operational and regulatory challenges of implementation of such trials are also discussed.
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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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