Elligo Health Research, a healthcare-enabling research organization, has received a grant from the U.S. FDA for a follow-on project to extend the value of common data harmonization in the generation of clinical evidence from real-world data (RWD) to support regulatory use.
 
This grant will enable Elligo to explore methodology and use cases to further goals of the 21st Century Cures Act related to facilitating data sharing. Achievements from the first phase of this project include mappings of multiple data models (OMOP, PCORnet, i2b2, and Sentinel) to the BRIDG Model (an HL7, CDISC, and ISO standard), a reference data model and terminology bindings. These products will be leveraged in the new project, along with HL7’s FHIR standard.
 
“This project has been challenging, but educational and rewarding for us as an institution participating in multiple research networks that currently request de-identified data in as many different formats,” said Samuel Volchenboum, MD, PhD, associate chief research informatics officer of the University of Chicago’s Center for Research Informatics. “We look forward to benefiting from the harmonization products in our future clinical research activities.”
 
“Elligo is pleased to have the opportunity to continue our work with FDA, NCATS, NCI, and data partners to apply learnings from the first phase of this project,” said Rebecca Kush, PhD, Elligo chief scientific officer. “An efficient learning health system to benefit patients will depend on broad adoption of harmonized data models and terminologies, while concurrently protecting data and reducing legal barriers to sharing research data.”
 
“Elligo is proud to support the FDA in this important project,” said John Potthoff, PhD, Elligo CEO. “Elligo’s mission, to enable community physicians and their patients to participate in research, will be facilitated through this work.”