CDRH: In-silico Clinical Trials

WO32: 1243 

Credits: 1 

Can in silico imaging trials play a role in the evaluation of new medical imaging systems? The VICTRE trial used computer-simulated imaging of 2986 in silico patients to compare digital mammography and digital breast tomosynthesis and found an improved lesion detection performance favoring tomosynthesis for all breast sizes and lesion types. The increased performance for tomosynthesis was consistent with results from a comparative trial using human patients and radiologists. The study's findings suggest that in silico imaging trials and imaging system computer simulation tools can in some cases be considered viable sources of evidence for the regulatory evaluation of imaging devices. We provide evidence that state-of-the-art computational methods coupled with laboratory testing can lead to less burdensome regulatory evaluation approaches.

Describe the main elements of an in silico clinical trial.|Discuss current state-of-the-art computational modeling of radiation medical imaging systems.|Explain the potential for computational models to minimize the needs for trials using human patients and medical practitioners. 

FDA Grand Rounds