NESTcc Research Methods and Data Quality Frameworks

The Research Methods and Data Quality 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.

The Frameworks build upon existing bodies of work and leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, FDA’s Sentinel Initiative, and MDEpiNet. They will be updated in the future based on key findings and lessons learned from NESTcc’s RWE Test-Case projects.

Research Methods Framework

The NESTcc Research Methods Framework is applicable to many different data sources and defines the key components of a study protocol for the evaluation of medical devices.

The document promotes overall study design, outlining principles to follow and evidentiary requirements for core elements including disease and device information, target population and patient selection, study outcomes and procedures, sample size, monitoring and statistical analysis.

Data Quality Framework

The NESTcc Data Quality Framework focuses primarily on the use of EHR data in the clinical care setting, and considers topics including data governance, characteristics, capture, transformation, and curation.

Within the framework, the NESTcc Data Quality Maturity Model addresses the varying stages of an organization’s capacity to support these domains, which allows collaborators to indicate progress toward achieving optimal data quality.

NESTcc Research Methods and Data Quality Subcommittees

NESTcc has established Research Methods and Data Quality Subcommittees to support its efforts to conduct efficient, timely, and high-quality real-world evidence (RWE) studies for medical devices.

Comprised of experts from health systems, academia, industry, and the U.S. Food and Drug Administration (FDA), the subcommittees have developed the NESTcc Research Methods and Data Quality Frameworks, designed processes for demonstrating conformance, and made recommendations for their implementation.

Current Members

  • Naomi Aronson, PhD, Blue Cross Blue Shield Association
  • *Jesse Berlin, ScD, Rutgers School of Public Health
  • Ulka Campbell, PhD, MPH, Aetion
  • Wei-Chen Chen, PhD, MS, FDA/OCEA
  • Graeme Hickey, PhD, Becton Dickinson
  • Mitchell Krucoff, MD, Duke University Medical Center/Duke Clinical Research Institute (DCRI)
  • Mwanatumu Mbwana, PhD, RAC, NESTcc
  • Didier Morel, PhD, Becton Dickinson
  • Jacqueline Puigbo, PhD, MS, FDA/CDRH/OCEA/OPEQ/Division of Clinical Science and Quality
  • Scott Snyder, PhD, Cook Research Incorporated
  • Shumin Zhang, MD, ScD, Johnson & Johnson

* Subcommittee chairperson

Past Members 2020-2021

  • Vandana Bhatia, PhD, U.S. Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)/Office of Clinical Evidence and Analysis (OCEA)/Office of Product Evaluation and Quality (OPEQ)
  • Nilay Shah, PhD, Mayo Clinic

Past Members 2019-2020

  • John Laschinger, MD, W.L. Gore and Associates
  • Heng Li, PhD, FDA/CDRH/OSB/DBS
  • Nilsa Loyo-Berrios, PhD, MSc, FDA
  • Joao Monteiro, PhD, Medtronic
  • Sharon-Lise Normand, PhD (Past Chair), Harvard Medical School/Harvard TH Chan School of Public Health

Current Members

  • Adam Atherton, MS, PE, RAC, Independent Consultant
  • Jeffrey Brown, PhD, TriNetX
  • Alexandra Cha, PhD, PMP, NESTcc/Booz Allen Hamilton
  • Jianxiong (George) Chu, PhD, MS, MS, Edwards Lifesciences
  • Paul Coplan, ScD, MBA, MPH, Johnson & Johnson
  • Adam Donat, JD, MS, FDA/CDRH/OCEA/Office of Product Evaluation and Quality (OPEQ)
  • Nicolle Gatto, PhD, MPH, FISPE, Aetion
  • Frederick Masoudi, MD, MSPH, Ascension
  • Drew Nelson, BSN, CCRN, Medtronic
  • Joe Ross, MD, MHS, Yale University
  • Art Sedrakyan, MD, PhD, Weill Cornell Medicine
  • James Tcheng, MD, Duke University Health System
  • Rebecca Torguson, MPH, FDA/CDRH

Past Members 2019-2021

  • 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
  • Edgar Simard, PhD, MPH, Medtronic
  • Kara Southall, MS, Medtronic
  • Karen Ulisney, MSN, FDA/CDRH/ODE/Clinical Trials Program
  • Charles Viviano, MD, PhD, FDA/CDRH/ODE/DRGUD