Activity Number:
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291
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Type:
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Contributed
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Date/Time:
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Wednesday, August 14, 2002 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section*
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Abstract - #300599 |
Title:
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Sample Size Re-estimation for Binary Data via Conditional Power
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Author(s):
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Cunshan Wang*+ and David Keller and Kuang-Kuo Lan
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Affiliation(s):
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Pfizer, Inc. and Pfizer, Inc. and Pfizer, Inc.
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Address:
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Eastern Point Rd, MS 8200-40, Groton, Connecticut, 06340, USA
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Keywords:
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Sample Size Re-estimation ; Conditional Power ; Binary Data ; Noninferiority ; Type I Error Rate
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Abstract:
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We extend Lan and Trost's (1997) conditional power approach for interim sample-size re-estimation to binary data for clinical trials with a noninferiority objective. If conditional power is used to extend a trial, the alpha level will be inflated. On the contrary, if it is used to stop a trial early to claim futility, the alpha level will be reduced. If inflation does not exceed deflation, then the alpha level will be maintained. Simulations were used to estimate probabilities of Type I error for a range of typical clinical trial situations in veterinary medicine. The results demonstrated that the procedure preserves Type I error rate.
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- Authors who are presenting talks have a * after their name.
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