Abstract #300599

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JSM 2002 Abstract #300599
Activity Number: 291
Type: Contributed
Date/Time: Wednesday, August 14, 2002 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section*
Abstract - #300599
Title: Sample Size Re-estimation for Binary Data via Conditional Power
Author(s): Cunshan Wang*+ and David Keller and Kuang-Kuo Lan
Affiliation(s): Pfizer, Inc. and Pfizer, Inc. and Pfizer, Inc.
Address: Eastern Point Rd, MS 8200-40, Groton, Connecticut, 06340, USA
Keywords: Sample Size Re-estimation ; Conditional Power ; Binary Data ; Noninferiority ; Type I Error Rate
Abstract:

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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