June 7, 2018 – The subcommittee will develop data quality standards for NESTcc partners and make recommendations for their implementation.
The DCRI’s Lesley Curtis, PhD, and James Tcheng, MD, have been named to the Data Quality Subcommittee of the National Evaluation System for health Technology Coordinating Center (NESTcc).
The Data Quality Subcommittee and a Methods Subcommittee will develop data quality and methodological standards for the NESTcc Network Collaborators, the organizations partnering with NESTcc to generate and analyze real-world data. The subcommittees will also design processes for demonstrating conformance to the standards and make recommendations for their implementation. These standards will build upon existing bodies of work and leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.
“Our Data Quality and Methods Subcommittees are comprised of national leaders in the areas of data quality and methods standards. Establishing these subcommittees is an essential step in ensuring confidence in the quality of medical device real-world data and real-world evidence generated by partnerships with NESTcc,” said Rachael L. Fleurence, PhD, Executive Director of NESTcc. “We look forward to their counsel and collaboration as NESTcc prepares to launch its first set of industry test cases to demonstrate the functionality of the NESTcc Data Network and we prepare to open the NESTcc Front Door for public inquiries for collaborating with the NESTcc Data Network.”
Curtis, who is the co-lead of the PCORnet Distributed Research Network Operations Center and previously co-led the Data Core for FDA’s Mini-Sentinel Initiative, will chair the Data Quality Subcommittee.
Data Quality Subcommittee Members
- Jeffrey Brown, PhD, Harvard Pilgrim HealthCare Institute/ Harvard Medical School
- Lesley Curtis, PhD, MS, Duke University School of Medicine
- Sarah Horn, PhD, Medtronic
- John Laschinger, MD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)/ODE/DCD/SHDB
- Aaron Lottes, PhD, Cook Research Incorporated
- Keith Marsolo, PhD, Cincinnati Children’s Hospital Medical Center
- Frederick Masoudi, MD, MSPH, University of Colorado Anschutz Medical Campus
- Joe Ross, MD, MHS, Yale University
- Art Sedrakyan, MD, PhD, Weill Cornell Medicine
- James Tcheng, MD, Duke University Health System
- Charles Viviano, MD, PhD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health CDRH/ODE/DRGUD
NESTcc was established in 2016 to support the sustainable generation and use of timely, reliable, and cost-effective real-world evidence throughout the medical device lifecycle, using real-world data that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making.