Keywords: Diagnostic Devices, device output, study protocol
Room: McKinley
This is a general topic on challenges associated with review of in vivo diagnostic devices. Many in vivo diagnostic devices involve multiple output and without clear specification of how these are to be interpreted in clinical practice. Diagnostic devices with quantitative and or qualitative output have different statistical challenges. This session will discuss the expectations in study protocol, device description -output(s), endpoints, hypothesis statements, and study designs.