American Statistical Association
New York City
Metropolitan Area Chapter

Virtual Seminar
March 21, 2024
3:00 - 5:00 PM (US ET)

The New York Metro Area Chapter of the American Statistical Association

Is Pleased to Invite You to a Virtual Seminar

Data Quality: From Frameworks to Screening


Kelly H. Zou
Marc L. Berger

The ASA Caucus of Industry Representatives (CIR) is a non-financial co-sponsor.


Part I: An Introduction to Real World Data (RWD) and Real-World Evidence (RWE)

Adoption and use of real-world data (RWD) for decision-making has been complicated by concerns regarding whether RWD was fit-for-purpose or was of sufficient validity to support the creation of credible RWE. This has greater urgency as regulatory agencies begin to use real world evidence (RWE) to inform decisions about treatment effectiveness. Researchers need an efficient and systematic method to screen the quality of RWD sources considered for use in studies of effectiveness and safety. In this part, DQFs in the United States (US) and European Union (EU) are reviewed, including their dimensions and sub-dimensions. There was some convergence of conceptual frameworks and there is much agreement on specific assessment criteria. In Part I of this workshop, we give an overview of RWD and RWE, along with relevant concepts in digital health and artificial intelligence (AI).

Part II: Data Quality Frameworks (DQFs) and a Screening Tool (ATRAcTR)

DQFs in the United States (US) and European Union (EU) are reviewed, including their dimensions and sub-dimensions. There was some convergence of conceptual frameworks and there is much agreement on specific assessment criteria. In Part II of this workshop, we describe a list of screening criteria that we have published to assess the quality of RWD sources. We also developed an additional criterion based on Modern Validity Theory. Consensus has yet to emerge on how to assess whether a specific RWD source is reliable and fit-for-purpose. To create a user-friendly tool to assess whether RWD sources may have sufficient quality to support a well-designed RWE study for submission to a regulatory authority, we grouped the quality criteria with a view to harmonize published frameworks and to be consistent with how researchers generally evaluate existing RWD sources for research that they intend to submit to regulatory agencies. Screening data quality criteria were grouped into five dimensions after a comprehensive literature review via PubMed: authenticity, transparency, relevance, accuracy, and track record. The resultant tool was tested for its response burden using a hypothetical administrative claims data source.


This was joint work with Marc L. Berger, William H. Crown, Jim Z. Li, and Kelly H. Zou.

Reference Material

Berger, M.L., Crown, W.H., Li, J.Z. et al. ATRAcTR (Authentic Transparent Relevant Accurate Track-Record): a screening tool to assess the potential for real-world data sources to support creation of credible real-world evidence for regulatory decision-making. Health Serv Outcomes Res Method (2023).


Speakers' Biography

Kelly H. Zou, Ph.D., PStat® is Head, Global Medical Analytics, Real-World Evidence, and Health Economics & Outcomes Research, Viatris Inc. She is an elected Fellow of the American Statistical Association and an Accredited Professional Statistician. Previously at Pfizer Inc, she was Vice President and Head of Medical Analytics & Insights; Senior Director of Real World Evidence, Group Lead of Methods & Algorithms and Analytic Science Lead; Senior Director of Statistics. She was Associate Professor of Radiology at Harvard Medical School, as well as Director of Biostatistics at its affiliated teaching hospitals. She was Associate Director of Rates at Barclays Capital. She received both MA and PhD degrees in Statistics from the University of Rochester. She completed her Postdoctoral Fellowship at Harvard. Her research interests include health policy, real world evidence, signal detection, and artificial intelligence, with over 155 professional articles and 5 books. She was featured as an Outstanding Woman in Data Analytics by Forbes, an Inspirational Women in Statistics & Data Science by Wiley, and an Accomplished Woman in Statistics and Data Science by the American Statistical Association. She was the winner of the Chief Data and Analytics Officers' Forum's Future Thinking Award, Reuters Events Pharma USA's Most Valuable Data & Insights Initiative Team Award, and CPhI Digital Innovation Team Award.

Dr. Zou has served the following leadership roles, among others: Chair and Secretary, ASA Health Care Policy Statistics Section (HPSS); Awards Committee Chair, Committee of Presidents of Statistical Societies (COPSS) Awards; Inaugural Executive Committee Member, Caucus of Industry Representatives (CIR); Chair and Vice Chair, ASA Statistical Partnerships among Academe, Industry, and Government (SPAIG) Committee; Vice Chair, Methods and Data Council, and Member, Membership Council, Academy Health.

Marc L. Berger, MD, is a semi-retired, part-time consultant and scientific advisor. Until July 2017, he was Vice President, Real World Data and Analytics at Pfizer, Inc. Marc has held senior-level positions in industry including Executive Vice President and Senior Scientist at OptumInsight; Vice President, Global Health Outcomes at Eli Lilly and Company; and Vice President, Outcomes Research and Management at Merck & Co., Inc. He was a temporary employee of CMS from July-December 2022.

Marc is an ISPOR Special Advisor for Real World Evidence and a member of the Duke-Margolis Center for Health Policy Real-World Evidence Collaborative. He has written or co-written more than 130 peer-reviewed articles, book chapters, and other publications on a range of topics including health services research, outcomes research, health economics, and health policy. His research efforts currently focus on real-world data and real-world evidence and how they can inform decision-making. His recent publication in Health Services and Outcome Research Methodology - ATRAcTR (Authentic Transparent Relevant Accurate Track-Record): A Screening Tool to Assess the Potential for Real-World Data Sources to Support Creation of Credible Real-World Evidence for Regulatory Decision-Making - appeared online in November 2023.

He received the Donabedian Lifetime Achievement Award from the Professional Society for Health Economics and Outcomes Research (ISPOR) in 2019.

Date and Time
Thursday, March 21, 2024
3:00 - 5:00 P.M. (US ET)

Virtual via Zoom

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