Design and Analysis Considerations for Precision Studies in In-Vivo Diagnostic Test Studies

• Activity Number: 261
• Type: Contributed
• Date/Time: Monday, August 1, 2016 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Changhong Song*
• Companies: FDA
• Keywords: precision ; repeatability ; reproducibility ; In-vivo diagnostic test

Abstract

The objectives of many clinical studies are to evaluate the precision of in-vivo diagnostic devices. For this type of studies, repeatability and reproducibility will usually be reported to support that the variability of a measurement is acceptable for a device. This study reviews common study designs and statistical analysis methods for this type of studies. Simulated data will be used to evaluate the adequacy of these study designs and analysis methods.