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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332
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307152 |
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Title:
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Applying Covariate-Adjusted, Response-Adaptive Randomization to Medical Device Studies
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Author(s):
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Thomas E. Gwise and Gene Anthony Pennello*+
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Companies:
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FDA and FDA
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Address:
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Division of Biostatistics, Silver Spring , 20993,
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Keywords:
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diagnostic ;
therapeutic ;
predictive biomarker ;
adaptive design
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Abstract:
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The Food and Drug Administration is seeing an increase in the number of therapeutic drug submissions in which a diagnostic device is required to determine the treatment target population. This presentation will discuss personalized medicine and evaluation of drug-diagnostic combinations from the perspective of the Biostatistics Division in FDA's Center for Devices and Radiological Health. A short introduction to the organization of FDA will be followed by some background on study designs used in marker/drug clinical trials, as well as a possible application of covariate adjusted response adaptive randomization in drug/diagnostic co-development situations.
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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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