JSM 2005 - Toronto

Abstract #304304

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 512
Type: Contributed
Date/Time: Thursday, August 11, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #304304
Title: Survival Analysis in Two-stage Randomization with Sequential Consent Information
Author(s): Abdus Wahed*+
Companies: University of Pittsburgh
Address: Department of Biostatistics, Pittsburgh, PA, 15217, United States
Keywords: Survival Analysis ; Two-stage designs ; Missing data
Abstract:

Two-stage randomization designs are employed frequently in clinical trials where patients are treated with two or more therapies in sequence. In such designs, patients are randomized to one of the possible induction therapies upon entry and, depending on their response, are randomized to one of the possible maintenance therapies with the goal of comparing the benefit of induction and maintenance combinations. Wahed and Tsiatis (2004) discuss the issues in estimating the survival distributions in such two-stage designs. Occasionally, such as with the randomization scheme, patient consent also is obtained sequentially before each randomization. In this study, we consider the estimation of survival distribution and related efficiency issues in two-stage randomization designs where patient consent is collected separately for each stage of therapy. We propose estimators and establish their large-sample properties and present simulation results comparing the performance of the proposed estimators.


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Revised March 2005