TL25: Missing Data Due to the Lack of a Reference Standard in Evaluation of Diagnostic Medical Devices
*Qin Li, FDA/CDRH Keywords: When evaluating the accuracy of a diagnostic medical device, either compare to the reference standard or to a predicate device that is already on the market, missing data, including missing reference standard, and/or missing test result (either from the single test or from any of the two tests), are commonly encountered. Reporting diagnostic results using only completers can introduce bias to the diagnostic accuracy estimates. And more sophisticated statistical approaches are needed. Discussions on experiences and possible solutions among industrial, academic and regulatory researchers are planned in this roundtable session.
|
Key Dates
-
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