Austin, Texas, June 19, 2018 (Business Wire) - Elligo Health Research, which offers the only platform that brings clinical research direct to clinical health care, announces that Flatiron Health and the University of Chicago have agreed to act as data partners in a federal project led by the FDA to develop and pilot a common data architecture. This common architecture will serve as the intermediary between various data sources, thereby streamlining patient-centered research using de-identified or aggregated data from the delivery of health care in routine clinical settings.
Elligo is leading an effort to test the FDA harmonization model, a part of the common data architecture. Its partners, using a variety of electronic health record systems, will provide de- identified or aggregated datasets for the safety assessment of new oncology therapies.
“Our goal at Elligo is not just to facilitate research,” said John Potthoff, PhD, CEO of Elligo Health Research. “We embrace the opportunity to bring these companies together to work toward better data usability and patient outcomes.”
“Clinical research drives progress in oncology,” said Sam Volchenboum, MD, PhD, MS, associate professor of pediatrics and the director of the Center for Research Informatics at the University of Chicago Medicine. “This project will speed the conversion of de-identified research study data to make it more useful for the development of much-needed therapies.”
“Our electronic health record (EHR) systems are specifically designed for oncology providers and patients,” said Amy Abernethy, MD, PhD, chief medical officer and chief scientific officer, Flatiron Health. “By participating in this effort, we hope to advance standards that make the data more accessible for researchers to analyze and ultimately accelerate the development of cancer therapies.”
Mitra Rocca, the FDA’s associate director of medical informatics and the FDA lead on the harmonization project, will chair a session that covers the use of real-world data, including EHR data, on Tuesday, June 26, at the Drug Information Association (DIA) 2018 Global Annual Meeting in Boston.
Elligo Health Research offers the only platform that brings clinical research to physician practices, accelerating the development of new pharmaceutical, biotechnology and medical device products and therapies. Our Goes Direct® approach uses state-of-the-art technology to compliantly leverage current electronic health record data and applies a proprietary, prescreening process to match protocol-eligible patients for participation in clinical studies. It is our mission to support 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.