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Activity Number:
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220
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Type:
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Invited
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Date/Time:
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Tuesday, July 31, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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ENAR
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| Abstract - #307653 |
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Title:
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Comparing Two-Stage Treatment Strategies Based on Sequential Failure Times Subject to Interval Censoring
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Author(s):
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Peter F. Thall*+ and Leiko H. Wooten and Nizar M. Tannir and Randall E. Millikan and Christopher J. Logothetis
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Companies:
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The University of Texas M.D. Anderson Cancer Center and The University of Texas M.D. Anderson Cancer Center and The University of Texas M.D. Anderson Cancer Center and The University of Texas M.D. Anderson Cancer Center and The University of Texas M.D. Anderson Cancer Center
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Address:
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Dept. of Biostatistics, Box 447, Houston, TX, 77030,
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Keywords:
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Clinical trials ; Dynamic treatment regime ; Interval censoring ; Simulation ; Treatment Policy ; Multi-stage therapy
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Abstract:
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For many diseases, therapy involves multiple stages, with treatment in each stage chosen based on the patient's current disease status and history of treatments and clinical outcomes. We present a statistical framework for clinical trials comparing two-stage strategies based on time to second disease worsening or discontinuation of therapy. Each patient is randomized among a set of treatments at enrollment. If disease worsening occurs the patient is re-randomized among a set of treatments excluding the treatment given initially. The goal is to select the best two-stage strategy in terms of overall failure time. We present a model accounting for non-constant failure time hazards, regression of second failure time on first worsening time, interval censoring and delay between the two stages of therapy. The method is illustrated by a metastatic renal cancer trial.
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