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Abstract Details
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Activity Number:
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319
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305040 |
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Title:
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Data-Driven Interim Analysis in Clinical Trials
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Author(s):
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Kuang-Kuo Lan*+
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Companies:
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Johnson & Johnson
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Address:
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920 Route 202, Raritan, NJ, 08869, United States
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Keywords:
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over-running ;
under-running
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Abstract:
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The alpha-spending function approach in clinical trial design requires pre-specification of the maximum information of the study. For budget or other logistic reasons, many trials are designed for maximum duration. Control of alpha becomes a concern when (1) the final maximum value of information is quite different from the pre-specified value, or, (2) the timing and frequency of interim data analysis are data-driven. We will review these two issues and present some existing solutions to minimize potential alpha inflation.
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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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