The US Food and Drug Administration (FDA) has granted an award to clinical research infrastructure provider, Elligo Health Research to evaluate a harmonised data model that will help in the safety assessment of new oncology therapies.
Data
Harmonisation of real-world data will allow the FDA to better understand the safety of various cancer immunotherapies that are already approved. However, there is currently a lack of interoperability to be able to do this as data is submitted from various sources.
Therefore, this FDA-led project will create a data architecture by bringing together multiple data models and should enable data to be aggregated and exchanged between existing data models. It is this approach that 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, PhD, Elligo’s scientific innovation officer. “Competing data models should not impede access to important information. We commend the FDA for spearheading this project.”
“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 honoured to be part of this project.”