This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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217
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Type:
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Invited
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Date/Time:
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Monday, August 2, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Statistics in Biopharmaceutical Research Journal
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Abstract - #306035 |
Title:
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Evaluating Medical Imaging Reader Performance in Clinical Trials
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Author(s):
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David L. Raunig*+ and Patricia English
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Companies:
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Pfizer Inc. and Pfizer Inc.
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Address:
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Eastern Point Rd., Groton, CT, 06340,
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Keywords:
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Reader/Rater ;
Performance ;
Agreement Rate ;
Adjudication ;
Kappa ;
Intraclass Correlation
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Abstract:
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Medical imaging in clinical trials is exploding within every therapeutic area. New imaging biomarkers are available for size measurements and functional descriptions of cellular and molecular function. Evaluation of these images relies heavily on human readers with their own biases and performance abilities. The FDA set guidelines for imaging trials for the use of multiple readers to reduce variance and protect against bias, and the abilities of readers can be critical for the successful conduct of a clinical trial. Reliable metrics to measure reader performance will consider disease prevalence, reader ability and drift, and data quality. We will address methods for evaluating reader performance, demonstrate their benefits and limitations. We will also present developments within the FDA concerning reader performance including the use of single-reader and local reader paradigms.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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