Non-inferiority and superiority trials in the context of diagnostic devices
*Yuying Jin, FDA/CDRH Lakshmi Vishnuvajjala, FDA/CDRH Keywords: diagnostic device, non-inferiority, superiority, sensitivity, specificity, paired data Extensive efforts have been invested on the study design and the statistical methodologies for non-inferiority and superiority trial in therapeutics. Many of their notions are helpful when evaluating non-inferiority and superiority testing in diagnostics. However, the performance of a diagnostic device is described in two dimensions: sensitivity and specificity. The non-inferiority and superiority comparing two devices are assessed by paired data. Appropriate statistical methodologies should be adopted to accommodate the paired data when calculating the confidence interval of performance estimates. This talk will discuss the statistical issues associated with the non-inferiority and superiority testing for diagnostic devices. It will also demonstrate pitfalls with examples and discuss statistical methodologies that may serve best in data analysis.
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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