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Activity Number:
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270
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309658 |
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Title:
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How Much Evidence Is Enough?
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Author(s):
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Kuang-Kuo Lan*+
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Companies:
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Johnson & Johnson PRD
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Address:
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920 Route 202, Raritan, NJ, 08869,
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Keywords:
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adaptive design ; inverse normal ; inverse chi-square
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Abstract:
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Control of the alpha level is a key issue in drug development. Even though the traditional alpha level is set to be 0.025 (one-sided), it is extremely difficult to control the realized alpha at the desired level, and the power of an experiment will be affected accordingly. Combining evidence in Phase IIB/III studies is just one way to reduce the over-conservatism for alpha-control and improve power in drug development.
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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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