In June 2018, NESTcc established Data Quality and Methods Subcommittees to support its efforts to conduct efficient, timely, and high-quality real-world evidence (RWE) studies for medical devices. The 12-member Data Quality Subcommittee and 9-member Methods Subcommittee are composed of representatives from health systems, including NESTcc Network Collaborators, medical device manufacturers, academics, and the U.S. Food and Drug Administration (FDA).
Each subcommittee has developed a Framework which build upon existing bodies of work and incorporate subcommittee members’ knowledge and experience from similar initiatives, including MDEPiNet, PCORnet, and Sentinel. The Frameworks are intended to serve as guides for medical device ecosystem stakeholders wishing to collaborate with NESTcc to ensure the quality of data and research methodology.
In future iterations, the Frameworks will be moving to a more complete version, incorporating other data sources for Data Quality assessment and further real-world evidence examples and best practices for methodology to provide a more complete resource for medical device ecosystem stakeholders.
The full press release can be found here.
Additional information about the Frameworks, including download links, can be found here.