A program funded by the Food and Drug Administration has selected an American College of Radiology-supported project in lung cancer screening as one of 11 projects assessing the benefits of real-world evidence to healthcare.
The National Evaluation System for Health Technology Coordinating Center (NESTcc) has picked the ACR’s Lung CT Screening Reporting and Data System, which is intended to standardize lung cancer screening and provide recommendations to manage use of the technology.
Participating with the ACR are Brigham & Women’s Hospital and Massachusetts General Hospital as implementation sites; GE Healthcare and Nuance as radiology workflow companies; and Aidence, Enlitic, Infervision and Mindshare Medical as algorithm vendors.
The ACR program intends to use a lung cancer screening registry that will enable data to be captured for quality reporting, a requirement providers will face from the Centers for Medicare and Medicaid Services in receiving payment for lung cancer screenings.
ACR executives say the study will seek to validate the use of artificial intelligence, as well as an AI surveillance model, to test an algorithm that can be used in lung cancer screenings. In backing the project, NESTcc hopes that the expected validation of this algorithm will provide knowledge that will be “scalable to other disease areas. It will include the capture of performance metrics within a national registry, linking both AI model validation and AI model surveillance, providing real-world evidence to measure safety and effectiveness.”
The ACR and other demonstration projects selected by NESTcc support its mission of establishing functional and efficient pathways for generating evidence on medical devices.
“Through the demonstration projects, NESTcc is engaging with national experts and leaders in the real-world evidence field from industry, academia and the FDA, and leveraging the lessons from their pioneering work to support NESTcc’s launch,” says Rachel L. Fleurence, its executive director.
The projects are already underway at participating organizations and are expected to be completed by the end of the year. The projects use a range of health technologies, including imaging technologies, medical devices and in vitro diagnostics in a variety of stages of development. Real-world data sources include different combinations of administrative claims, electronic health records, and patient and device generated data—this information will be linked to provide data suitable for generating “robust evidence,” NESTcc executives say.
NESTcc was established in 2016 through $3 million in seed funding from the FDA to the Medical Device Innovation Consortium, a public-private partnership created to advance medical device regulatory science through the total product lifecycle.
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