Abstract #301294

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JSM 2003 Abstract #301294
Activity Number: 176
Type: Contributed
Date/Time: Monday, August 4, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301294
Title: Two-Stage Adaptive Design for Clinical Trials With Survival Data
Author(s): Gang Li*+ and Weichung J. Shih and Yining Wang
Companies: Organon Inc. and University of Medicine and Dentistry of New Jersey and University of Rochester
Address: 375 Mt. Pleasant Ave., West Orange, NJ, 07052-2724,
Keywords: adaptive design ; censored survival data ; conditional power
Abstract:

In clinical trials to compare treatment effect on a survival endpoint, sample size adjustment may be desired. We take the conditional power approach based on the idea of Li, Shih, Xie and Lu (2002) for trials with survival endpoint. We focus on only two stages here, since (a) it is easy to illustrate our method, (b) two-stage designs are most frequently used among all sequential designs in practice, and (c) particular for changing the course of a long-term trial midstream, two-satge is more realistic in terms of logistic feasibility. The essence of our adaptive design is to use the conditional power at the first stage to determine the number of events needed for the second stage. Then, based on the observed event rate, pattern of the enrollment and compliance of patients to project the number of patients and study duration required

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