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.
About Elligo
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.
CONTACT:
Lea Studer
SCORR Marketing
402.366.1752
lea@scorrmarketing.com
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Zenocutuzumab Shows Durable Efficacy in NRG1 Fusion-Positive Cancers in Phase II eNRGy Trial
February 13th 2025The Phase II eNRGy trial showed durable antitumor activity with zenocutuzumab (Bizengri) in patients with NRG1 fusion–positive cancers, particularly non-small cell lung cancer and pancreatic cancer.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.