Showing Clinical Utility of a Diagnostic Test by Evaluating Agreement with a Reference Test: Study DesignIissues
View Presentation *Ann Olmsted, CV Therapeutics, Inc. *Whedy Wang, CV Therapeutics, Inc. Keywords: kappa, agreement, non-inferiority The goal is to establish the clinical utility of a medical test used to guide patient management when no generally accepted gold standard test exists. Our approach is to show sufficient agreement with a reference test of known clinical utility to ensure that the new test will have comparable utility. Some of the many issues in designing studies that follow this approach will be discussed, including choice of primary measure of agreement, choice of primary test of hypotheses, and choice of non-inferiority margin.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC