National Evaluation System for health Technology Coordinating Center Announces Launch of NEST 1.0
Summary
“We will continue to innovate using novel methods to inform clinical, regulatory, and reimbursement decision-making, empowering medical device stakeholders with evidence that is vital to improving patient health outcomes.” NESTcc brings scientific rigor to research by building in quality by design. Through its Research Network of health systems, registries, and consortia, NESTcc connects stakeholders with expert investigators and diverse sets of traditionally disparate RWD to evaluate medical technologies across device types, disease areas, and stages of the total product lifecycle. “NEST will advance the creation of a true learning system that allows for the ongoing evaluation of technology across the total product life cycle,” said Jeff Shuren, M.D., J.D., director of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, and NESTcc Governing Committee member. The Coordinating Center seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using high-quality Real-World Data (RWD) that meets robust methodological standards for the purpose of enhancing regulatory and clinical decision-making. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.