The Mary Tyler Moore Vision Initiative hosted a workshop titled “Data Harmonization, Standardization, and Collaboration for Diabetic Retinal Disease: Accelerating the Development of New Indications, Therapies, and Regulatory Pathways” on May 7, 2024, in Seattle, WA. We extend our gratitude to the more than 60 attendees, who brought together research expertise from industry, academia, government, and non-profit organizations. Collaborative efforts are essential to advancing the search for a cure for vision loss and blindness caused by diabetes. Effectively handling and managing both research and real-world patient data is crucial to achieving this goal.
Objective: To outline best practices and specific considerations for building a large, shareable MTM Vision data lake, including methods for clinical data standardization and harmonization of ‘omics analyses.
Setting the Stage (Introductions and Welcome)
S. Robert Levine, MD, Founder and CEO, The Mary Tyler Moore Vision Initiative
o Major goals of MTM Vision.
Michael Chiang, MD, Director, National Eye Institute, National Institutes of Health
o Importance of data harmonization, standardization, and collaboration.
Building a Data Lake
Speakers: Aaron Lee, MD MSCI, Associate Professor of Ophthalmology, University of Washington, PI of NIH’s Bridge2AI AI-READI project.
Panel Moderator: Jennifer Sun, MD, MPH, Science Co-Director, The Mary Tyler Moore Vision Initiative; Associate Professor of Ophthalmology, Harvard Medical School; Chair, Diabetes Initiatives, DRCR Retina Network.
Panelists:
o Sally Baxter, MD, MSc, Assistant Professor of Ophthalmology, University of California San Diego.
o Drew Lewis, Co-Founder/President, Estenda Solutions, Inc.
o Paolo Silva, MD, Assistant Chief of Telemedicine, Beetham Eye Institute, Joslin Diabetes Center; Associate Professor of Ophthalmology, Harvard Medical School.
Topics for Consideration:
o What are the important considerations in data acquisition for clinical data, images, and ‘omics data?
o How do we structure the data lake to best promote future sharing of this resource?
o Who will contribute to the data lake? How does this relate to other ongoing efforts?
o What are the qualifications that will make data/cohorts eligible or ineligible for participation?
o Will the data lake be centralized or decentralized?
Data Standardization
Speakers: Kerry Goetz, MS, Associate Director, NEI Office of Data Science and Health
Informatics and Brian VanderBeek, MD, MPH, MSCE, Assistant Professor of Ophthalmology, University of Pennsylvania Scheie Eye Institute.
Panel Moderator: Thomas Gardner, MD, MS, Science Co-Director, The Mary Tyler Moore Vision Initiative; Professor of Ophthalmology and Visual Sciences, University of Michigan.
Panelists:
o Michelle Hribar, PhD, DATA Scholar, National Eye Institute; Associate Professor of
Ophthalmology and Medical Informatics and Clinical Epidemiology, Oregon Health &
Science University.
o Emily Chew, MD, Director of the Division of Epidemiology and Clinical Applications, National Eye Institute.
Topics for Consideration:
o What will it take to standardize the data in the MTM Vision data lake?
o To which common data element models should MTM Vision data be mapped (e.g. CDISC,
OMOP, etc.)?
o What are the considerations in mapping clinical trial/study data vs electronic
health record datasets?
o What is the status of other major ophthalmic data efforts in terms of
standardization and are there opportunities to collaborate with these groups?
o What are the potential use cases for reuse of the data that are collected?
Standardization of Sample Collection, Characterization, and Storage and ‘Omics Analyses for Ocular Tissues and Fluids
Speaker: Jeffrey Sundstrom, MD, PhD, Assistant Professor, Pennsylvania State College of
Medicine.
Panel Moderator: Patrice Fort, PhD, MS, Director, The Mary Tyler More Vision Initiative Biorepository & Resource Center; Associate Professor of Ophthalmology and Visual Sciences, University of Michigan.
Panelists:
o Vinit Mahanjan, MD, PhD, Professor of Ophthalmology, Stanford Medicine.
o Stephen Kim, MD, Phyllis S. and William B. Snyder Chair and Retina Division Chief,
Vanderbilt University Medical Center.
o Remko Bakker, PhD, Director CardioMetabolic Diseases Research, Boehringer Ingelheim.
Topics for Consideration:
o What ‘omics analyses should be performed/encouraged for ocular tissues and fluids in
eyes with DRD?
o What are the best ways to encourage collaboration between groups performing ‘omics
research in ophthalmology?
o What are the considerations in creating ‘omics data sets that will ensure harmonization of data and the ability for easy sharing?
Opportunities for Collaboration with NIH, FDA, Foundations, International Organizations, and Industry
Panel Moderator: S. Robert Levine, MD, Founder and CEO, The Mary Tyler Moore Vision Initiative.
Panelists:
o Thomas Brunner, President and CEO, Glaucoma Research Foundation.
o Ulrich Luhmann, PhD, Biomarker Experimental Medicine Leader, Translational Medicine Ophthalmology, Roche Innovation Center.
o Tunde Peto, MD, PhD, Professor of Clinical Ophthalmology, Queens University Belfast, EA Study of Diabetic Eye Complications Study Group; ESAB.
Topics for Consideration:
o How can MTM Vision coordinate efforts with NEI and FDA to encourage the standardization of ophthalmic data and build shareable data warehouses for ophthalmic efforts?
o How can we strengthen existing or build new collaborative efforts with NIH, regulatory agencies, industry, and international organizations that encourage data standardization and sharing of datasets?
o Are there potential RFAs that would be of interest to NEI and/or NIDDK around the creation of data lake resources? Are there any funding mechanisms available from regulatory bodies for these types of activities?
o How do we incentivize data sharing across clinical practices and academic centers? Are there NIH initiatives that can be developed to encourage a data-sharing culture?
Summation and Next Steps
Jennifer Sun, MD, MPH, Science Co-Director, The Mary Tyler Moore Vision Initiative; Associate Professor of Ophthalmology, Harvard Medical School; Chair, Diabetes Initiatives, DRCR Retina Network.
Thank You and Invitation to MTM Vision Fall Symposium
S. Robert Levine, MD, Founder and CEO, The Mary Tyler Moore Vision Initiative.
