NESTcc has established Data Quality and Methods Subcommittees 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, 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.
Data Quality and Methods Subcommittee Membership
Data Quality Subcommittee Members
- Jeffrey Brown, PhD, Harvard Pilgrim HealthCare Institute/ Harvard Medical School
- Lesley Curtis, PhD, MS, Duke University School of Medicine*
- John Laschinger, MD, W. L. Gore and Associates
- Aaron Lottes, PhD, Cook Research Incorporated
- Keith Marsolo, PhD, Duke University
- Frederick Masoudi, MD, MSPH, University of Colorado Anschutz Medical Campus
- Mary Ritchey, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)
- Joe Ross, MD, MHS, Yale University
- Art Sedrakyan, MD, PhD, Weill Cornell Medicine
- Kara Southall, MS, Medtronic
- James Tcheng, MD, Duke University Health System
- Karen Ulisney, MSN, FDA/CDRH/ODE/Clinical Trials Program
- Charles Viviano, MD, PhD, FDA/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
