The FDA has tasked Elligo Health Research to evaluate a harmonized data model the agency built so that real-world data collected from different sources could talk to each other.
There are several ways to collect and represent real-world data, but a lack of common structure that allows researchers to combine and analyze data from different sources severely limits their usefulness.
Rebecca Kush, Ph.D., Elligo’s scientific innovation officer, offered two examples where such data can show up differently. For example, for gender, different systems could record as M or F, 0 or 1, or Man or Woman, and some can have as many as 15 choices just for gender. Others like the severity of an adverse event could be recorded in different level matrices that usually requires human translation to put into a standard format.
To overcome that barrier and facilitate the use of real-world data to help generate evidence for regulatory and clinical decision-making, the FDA initiated a project called “Harmonization of Various Common Data Models and Open Standards for Evidence Generation.”
Funded through the Patient-Centered Outcomes Research Trust Fund available under the Affordable Care Act, the project has developed a common data architecture dubbed the BRIDG that allows data to be exchanged between models.
“The BRIDG will serve as the overarching harmonizer or intermediary to allow the data to be converted to a single format such that they can be aggregated into one database,” explained Kush.
Now, Elligo has been awarded a grant by the FDA to test the approach in a use case that entails gathering real-world data to aid in the safety evaluation of newly approved immunotherapies.
Elligo will evaluate potential data sources to ensure that they can provide safety data and other relevant clinical data in one of the predesignated models and oversee the use case activities, and the FDA will examine the data for safety profile analyses, Kush told FierceCRO. “Through this project, Elligo will learn more about using EHRs as potential eSource data sources for research,” she said.
The immunotherapy safety assessment case will last for about a year, Kush said, and progress on this project will be shared at next year’s Bridging Clinical Research & Clinical Health Care Collaborative.