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Activity Number: 225
Type: Topic Contributed
Date/Time: Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
Sponsor: Section on Statistics in Epidemiology
Abstract - #302491
Title: Capturing Performance of Prognostic Markers: An Overview
Author(s): Estelle Russek-Cohen*+ and Harry F. Bushar and Iram Quraishi
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 1350 Piccard Drive, HFZ-550, Rockville, MD, 20850,
Keywords: Biomarkers ; study designs ; prognosis
Abstract:

Prognostic markers are those designed to group patients that have already been diagnosed with a disease into risk strata. They provide information to physicians by identifying those patients that may be considered for more or less aggressive therapy. This article describes some of the challenges in evaluating prognostic markers including aspects of study design, performance metrics and reporting guidelines.

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