Non-Inferiority Studies for Diagnostic Devices
*Lakshmi Vishnuvajjala, FDA\CDRH Keywords: Sensitivity, Specificity, predictive values, Likelihood raios Non-inferiority studies are more complex for diagnostic devices as they usually involve two performance measures like sensitivity, specificity, or positive and negative predictive values or positive and negative likelihood ratios; if both measures of a pair are higher, or both lower, we can say one test is better, or worse than the other. If one is higher and one is lower, it is not always easy to determine which test is a better test. It depends not only on the magnitude of the difference, but also on the consequences of misclassification. For screening tests for example, this could also depend on the next step in the patient work-up. Area under the ROC curve is considered sometimes, but it can be problematic, as the consequences of false positives and false negatives can vary greatly not only between devices, but even for the same device, depending on the context in which it is used. We will consider some of these issues in determining non-inferiority of diagnostic tests.
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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