JSM 2005 - Toronto

Abstract #304783

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Activity Number: 100
Type: Contributed
Date/Time: Monday, August 8, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304783
Title: Efficiencies and Challenges of Two-stage Randomization Designs
Author(s): Jeffrey Helterbrand*+
Companies: Genentech, Inc.
Address: 1 DNA Way, South San Francisco, CA, 94080, United States
Keywords: two-stage randomization design ; time-to-event ; Cox regression ; inverse-probability weighting
Abstract:

Two-stage randomization designs (TSRDs) are becoming increasingly popular in cancer and AIDS time-to-event clinical trials. In particular, such designs can address whether a new agent should be added as a new component to standard of care (SOC) induction treatment, be used as a maintenance treatment after SOC induction, or be used in both the induction and maintenance setting. In many instances TSRDs can address these questions with either fewer patients, less time, or both fewer patients and less time than conducting multiple single randomization trials. However, the efficiency gains of TSRDs may be obscured by issues related to their use. Methods to address these issues are discussed and the potential efficiencies of TSRDs are illustrated.

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Revised March 2005