Elligo Health Research, a specialist clinical research infrastructure provider, has received an FDA award to evaluate the use of harmonised data models to gather real-world data, which will aid in the safety assessment of new oncology therapies
While the US Food and Drug Administration (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 analyse data, thus severely limiting its usefulness.
The FDA is leading a project to harmonise 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.
Dr Rebecca Kush, Scientific Innovation Officer at Elligo, said: “A data architecture and process that enable meaningful data exchange will allow us to leverage real-world evidence and patient experiences to accelerate learning. Competing data models should not impede access to important information. We commend the FDA for spearheading this project.”