Abstract #300136

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JSM 2002 Abstract #300136
Activity Number: 64
Type: Topic Contributed
Date/Time: Monday, August 12, 2002 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section*
Abstract - #300136
Title: General Two-Stage Adaptive Designs With Dependent Data
Author(s): Qing Liu*+
Affiliation(s): R.W. Johnson Pharmaceutical Research Institute
Address: 920 Route 202, P.O. Box 300, Raritan, New Jersey, 08869, U.S.
Keywords: Adaptive design ; Conditional error function ; Construct parameters ; Sample size adjustment ; Type I error rate ; Unbiased estimator
Abstract:

Theoretical considerations are given to general two-stage adaptive designs for clinical trials where data from the two stages are dependent. This occurs when additional data are obtained from patients during their second-stage follow-up. While the proposed flexible approach allows modifications of trial design, sample size adjustment, and improvement of statistical analysis using the first-stage data, the final analysis integrates data from both stages. The basic theory is developed for testing against a global as well as individual null hypotheses, for calculating overall adjusted p-values, and for obtaining unbiased point estimations and confidence intervals for parameters that are invariant to adaptations. Various examples are used for illustration. The two-stage adaptive design of Bauer and Kohne (1994) is a special case, which is further justified by the theory developed.

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Revised March 2002