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Abstract Details

Activity Number: 113
Type: Topic Contributed
Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #306859
Title: Surrogate Endpoint: New Statistical Definition and Evaluation
Author(s): Yongming Qu*+
Companies: Eli Lilly and Company
Address: , Indianapolis, IN, 46033, USA
Keywords: biomarker ; surrogate marker ; surrogate endpoint
Abstract:

Statistical definition and evaluation of the surrogate endpoint can be dated back to Prentice (Statistics in Medicine, 1989: 8: 431-440). Prentice proposed a necessary and sufficient condition for surrogate endpoint and a set of operational criteria. Subsequent work includes the concept of proportion of treatment effect and general association for both individual studies and meta-analysis approach. There seems a confusion among which statistical methods are appropriate to use. This research will review the existing methods and provide new definitions of biomarker, surrogate marker and surrogate endpoint. A new concept for the evaluation of surrogate endpoint will also be provided with some examples from clinical trials.


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