Elligo Health Research, a clinical research infrastructure provider, has received an FDA award to evaluate the use of harmonized data models to gather real-world data, which will aid in the safety assessment of new oncology therapies.

While the FDA has already approved various cancer immunotherapies, the agency seeks to better understand their safety in a real-world setting. However, there are multiple ways to collect and represent data, and there is a lack of interoperability—the capability for systems to exchange and aggregate data from various sources. This leads to an inability to combine and analyze data, thus severely limiting its usefulness.

The FDA is leading a project to harmonize various data models so that important data can be more easily shared and interpreted. The resulting data architecture will allow data to be exchanged between existing data models. This approach will be tested by Elligo, using electronic health records as data sources. 

“A data architecture and process that enable meaningful data exchange will allow us to leverage real-world evidence and patient experiences to accelerate learning,” said Rebecca Kush, Ph.D., Elligo’s scientific innovation officer. “Competing data models should not impede access to important information. We commend the FDA for spearheading this project.”

Having this data architecture facilitates data pooling for analysis, making it easier to support evidence-based care and increasing the value of patients participating in research studies.

“While the promise of real-world data for research is great, the ultimate value comes from being able to rapidly share high-quality data from electronic health records,” said Chad Moore, Elligo president. “We’re honored to be part of this project.”