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Activity Number:
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476
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305710 |
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Title:
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An Observational Error Model to Investigate Discordance in Oncology Studies with Progression-Free Survival
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Author(s):
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Frank Mannino*+ and Ohad Amit
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Companies:
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GlaxoSmithKline and GlaxoSmithKline
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Address:
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1250 South Collegeville Road, Collegeville, PA, 19426,
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Keywords:
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discordance ; progression-free survival
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Abstract:
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To confirm results obtained from local evaluation at investigational centers, many oncology studies utilize blinded independent central review (BICR) to make assessments of the primary endpoint, progression free survival (PFS). The comparison of data often leads to large discordances between these observations, casting doubt on the reliability of the estimated treatment effects from these trials. Here we present a new model of observational error that can be used to describe the discordance in patient assessments between multiple readers. The standard methods of measuring discordance are discussed along with newer measures that can better detect potential biases in investigator assessments.
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