JSM 2011 Online Program

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Abstract Details

Activity Number: 457
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302631
Title: Minimum Statistical Standards for Biomarker Development
Author(s): Jae Kyun Lee*+
Companies: University of Virginia
Address: POBOX 800717, Charlottesville, VA, 22911,
Keywords: biomarker ; SBIG ; StatBDS
Abstract:

Development of predictive molecular and clinicopathological biomarkers for disease diagnosis, prognosis and therapeutic response is critical for continuous efforts in personalized medicine. Recent biomarker developments have become extremely challenging statistically, especially since a vast amount of molecular and clinicopathological data are commonly utilized in these developments. The so-called Statistical Biomarker Interest Group (SBIG), consisting of >40 statistical biomarker scientists from FDA, industry, and academia, was formed in 2010. SBIG is currently making efforts to derive a consensus opinion on the most essential statistical issues and criteria for biomarker development, termed as "Minimum Statistical Biomarker Development Standards (StatBDS)."


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