Elligo Receives FDA Award to Evaluate Harmonized Data Model for Safety Assessment of New Oncology Therapies
Elligo Health Research, a leading 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 U.S. Food and Drug Administration 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.”
About Elligo
Elligo
Health Research offers the only platform that brings clinical
research to the clinic, accelerating the development of new
pharmaceutical, biotechnology and medical device products and therapies.
Elligo Goes Direct™ with an approach thatuses electronic
health records and other health data to identify real-world patients and
physicians for participation in clinical studies. Elligo supports health
care providers by providing personnel, procedures, technology and
infrastructure for clinical research, enabling patients to participate
in research while remaining under the care of their own trusted
physician. Learn more at elligodirect.com.
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