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, PhDHarvard Pilgrim HealthCare Institute/ Harvard Medical School
  • Lesley Curtis, PhD, MS, Duke University School of Medicine*
  • John Laschinger, MDU.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)/ODE/DCD/SHDB
  • Aaron Lottes, PhDCook Research Incorporated
  • Keith Marsolo, PhDDuke University
  • Frederick Masoudi, MD, MSPHUniversity of Colorado Anschutz Medical Campus
  • Joe Ross, MD, MHSYale University
  • Art Sedrakyan, MD, PhDWeill Cornell Medicine
  • Kara Southall, MSMedtronic
  • James Tcheng, MDDuke University Health System
  • Karen Ulisney, MSNU.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)/ODE/Clinical Trials Program
  • 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, ScDJohnson & Johnson
  • Mitchell Krucoff, MDDuke University Medical Center/Duke Clinical Research Institute (DCRI)
  • Heng Li, PhDU.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)/OSB/DBS
  • Nilsa Loyo-Berrios, PhD, MScU.S. Food and Drug Administration (FDA)
  • Joao Monteiro, PhDMedtronic
  • Didier Morel, PhDBecton Dickinson
  • Sharon-Lise Normand, PhD, MScHarvard Medical School*
  • Nilay Shah, PhDMayo Clinic
  • Scott Snyder, PhDCook Research Incorporated

* Subcommittee chairperson

Follow us @NESTccMedTech

Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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