Real World Data and Electronic Health Records in Clinical Research

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Real-world data are routinely collected about the patient health status or health care from a variety of sources (e.g., electronic health records (EHRs); claims and billing; disease registries; patient-generated input; mobile devices). Such data are increasingly used in research and development, especially during the current pandemic. This Virtual Workshop will provide a forum for presentations and discussions around the latest trends, and most up-to-date methods of using real world data. The constructive and practical messages should benefit principal investigators, research laboratory leaders, as well as users of clinical research discoveries.

The aim of this workshop to answer the following questions:

• What are the latest trends of using real world evidence?
• What are the state of the art tools of processing real world data and producing evidence?
• How to meet NIH expectations for research productivity in the use of real world data most effectively?

11:00 AM
Welcome and introductions

11:05 AM
Andrew Balas, MD, PhD
Plenary: Transition to Real World Data in Policy-Making

David Blumenthal, MD, MPP, President, The Commonwealth Fund
Discussion

11:20 AM
Panel I: Using Real World Data in Research – Why and How?
Moderator: George Lundberg, MD
Jeffrey Brown, PhD – Associate Professor in the Department of Population Medicine (DPM) at Harvard Medical School and the Harvard Pilgrim Health Care Institute; FDA Sentinel Initiative
Amy Abernethy, MD. – Principal Deputy Commissioner and Acting Chief Information Officer, FDA

Discussion

12:05 AM
Break

12:10 PM
Panel II: New Technologies and Data Analytics

Moderator: Doug Fridsma, MD, PhD
Holly Rimmasch, BSN, MS – Chief Clinical Officer of Health Catalyst
Matvey Palchuk, MD, MS – Vice President, Informatics – TriNetX, Inc. Cambridge, MA.

Discussion

12: 50 PM
Closing comments