ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc) has established a Data Quality Subcommittee and a Methods Subcommittee to support its efforts to conduct efficient, timely, and high-quality real-world evidence studies for medical devices. Each 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 (RWD) – 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.”
The subcommittees are comprised of members with a diverse set of stakeholder perspectives, including the FDA, academia, industry, and society registries, who bring expertise from other national data initiatives and device-specific partnerships. Lesley Curtis, PhD, of the Duke University School of Medicine will chair the Data Quality Subcommittee. Dr. Curtis 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. Sharon-Lise Normand, PhD, MSc of the Harvard Medical School will chair the Methods Subcommittee. Dr. Normand has served as the Director of the MDEpiNet Methodological Center and as Vice Chair of the PCORI Methodology Committee.
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
*Subcommittee chairperson
Methods Subcommittee Members
- Jesse Berlin, ScD, Johnson & Johnson
- Mitchell Krucoff, MD, Duke University Medical Center/Duke Clinical Research Institute (DCRI)
- Heng Li, PhD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health CDRH/OSB/DBS
- Nilsa Loyo-Berrios, PhD, MSc, U.S. Food and Drug Administration (FDA)
- Joao Monteiro, PhD, Medtronic
- Didier Morel, PhD, Becton Dickinson
- Sharon-Lise Normand, PhD, MSc, Harvard Medical School*
- Nilay Shah, PhD, Mayo Clinic
- Scott Snyder, PhD, Cook Research Incorporated
* Subcommittee chairperson
For more information about NESTcc Data Quality and Methods Subcommittees, please visit: https://nestcc.org/about/governance/
About the National Evaluation System for health Technology Coordinating Center
In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). 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 Real-World Data (RWD) 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. For more information, visit http://www.nestcc.org.
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.
Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (1 U01 FD 006292-01). 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.
