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Activity Number: 154
Type: Contributed
Date/Time: Monday, August 7, 2006 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305607
Title: Confidence Intervals Following an Adaptive Group Sequential Design
Author(s): Cyrus Mehta*+
Companies: Cytel Inc.
Address: 675 Massachusetts Ave., Cambridge, MA, 02139,
Keywords: adaptive clinical trials ; group sequential ; repeated confidence intervals ; median unbiased estimates ; Muller and Schafer
Abstract:

This paper proposes a method for computing confidence intervals with exact or conservative coverage following a group sequential test in which an adaptive design change is made one or more times over the course of the trial. The key idea, due to Muller and Schafer (2001), is that by preserving the null conditional rejection probability of the remainder of the trial at the time of each adaptive change, the overall type I error, taken unconditionally over all possible design modifications, also is preserved. This idea is further extended by considering the dual tests of repeated confidence intervals (Jennison and Turnbull 1989) and of stage-wise adjusted confidence intervals (Tsiatis, Rosner, and Mehta 1984). The method extends to the computation of median unbiased point estimates.

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