This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 566
Type: Topic Contributed
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307226
Title: Regulatory issues associated with the use of diagnostic test in a screening study
Author(s): Kyunghee Kim Song*+
Companies: FDA/CDRH
Address: 10903 New Hampshire Ave., Silver Spring, MD, 20993,
Keywords: screening study ; diagnostic test ; bias

There has been a great deal of interest in the use of biomarkers to drive regulatory decision for patients with clinical symptoms/diseases. Targeted therapies are often tied to a particular biomarker but how that marker is assessed using a diagnostic device can vary considerably. It is unclear how one then can tie biomarker performance to what counts, what it predicts in terms of survival endpoints for a patient. I will consider different scenarios of diagnostic performance from a statistical point. Finally, I would like to address some regulatory concerns.

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Authors who are presenting talks have a * after their name.

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