This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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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 - #305985 |
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Title:
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Statistics in Biopharmaceutical Research: Application of Biomarkers in Drug Development
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Author(s):
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Aloka Chakravarty*+ and Mark Rothmann and Rajeshwari Sridhara
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Companies:
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FDA and FDA and FDA
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Address:
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7730 Larel Leaf Drive , Potomac , MD, 20854,
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Keywords:
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biomarker ;
regulatory ;
prognostic ;
predictive ;
oncology
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Abstract:
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Regulatory Issues in use of Biomarkers in Oncology Trials?
Aloka G. Chakravarty, Ph.D., Mark Rothmann, Ph.D., Rajeshwari Sridhara, Ph.D. Office of Biostatistics, CDER, FDA
Abstract:
In the current era of personalized medicine, there has been an increased interest in biomarkers as a classifier for patient risk cohorts as well as a predictor of success for a therapeutic intervention. They hold promise to better screen patients who may or may not benefit from a particular treatment, but may experience toxicity inherent in oncology treatments. However, in general the classifier biomarkers are identified in post-hoc subgroup analyses. In this article we discuss the challenges in ascertaining true positive results from such post-hoc analyses.
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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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