Abstract #301551

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JSM 2003 Abstract #301551
Activity Number: 470
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #301551
Title: Two-Stage Designs for Stratified Phase 2 Clinical Trials
Author(s): Myron N. Chang*+ and Wendy B. London
Companies: University of Florida and University of Florida
Address: 1705 North West 22nd St., Gainesville, FL, 32605-3943,
Keywords: locally most powerful test ; error probability spending function ; multinomial distribution
Abstract:

Exact global tests of response rates for stratified Phase 2 clinical trials are proposed. Such a test is analogous to that of a stratified log-rank test for time-to-event data. Unconditional tests and tests conditional on the observed sample size within each stratum are considered. For large sample sizes, an asymptotic approach or a simulation approach are shown to be less computationally intensive and still quite accurate. These methods are useful for designing 2-stage stratified phase 2 clinical trials. An application to a Phase 2 clinical trial in neuroblastoma is presented.

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