Elligo advancing RWD project under FDA grant
The US Food and Drug Administration (FDA) is working with several partners as part of the Common Data Model Harmonization (CDMH) project, which aims to further the goals of the 21st Century Cures Act.
Phase one included the successful mapping of various data models, including OMOP, PCORnet, i2b2, and Sentinel, to the BRIDG Model, which is an HL7, CDISC, and ISO standard. A reference data model and terminology bindings also were developed and will be used in the next phase of the project.
While the first phase focused on the safety of patients taking new immunotherapies for cancer, the next phase will have a different use case and leverage the HL7 FHIR standard in accessing the data from electronic health records (EHRs), explained Rebecca Kush, PhD, chief scientific officer, Elligo, who said the grant will be used to fund Elligo’s participation in the cross-agency project team.
“The next step will be a planning session with the project team and discussions with FDA around the use case, which will define the ‘study,’” Kush told us.
The company will provide input into the next use case and prepare templates that will focus efforts to identify patients fitting the use case. Additionally, Elligo will find and prepare data partners to run the use case queries, while documenting the results and learnings.
“We are hoping that the important work that was done in the first phase of this project, including the mappings and harmonization of the various models with the BRIDG model and the terminology bindings (e.g., C-Codes) done by NCI to complement these, will be leveraged in this coming phase,” Kush said.
“It is extremely encouraging to see NIH/NCATS, NIH/NCI, and FDA collaborating closely on this project and related work,” she added. “Such collaborations are invaluable in bridging research and health care for the benefit of patients.”