ConcertAI and the FDA to Collaborate to Advance the Knowledge on the Potential Uses of Real-World Evidence

• The Collaboration Will Help in Gaining Rapid Insights Into More Effective Treatments for Cancer Patients Utilizing Concertai’s Oncology Real-World Data

ConcertAI is embarking on a five-year collaborative research program with the U.S. Food and Drug Administration, “Evaluation of Real-World Outcomes and Safety in the Treatment of Cancer.” The collaboration will utilize ConcertAI’s oncology real-world data (RWD) and advanced AI technology solutions to derive Real-World Evidence (RWE) across a variety of clinical and regulatory use cases. The agreement is with the FDA’s Center for Drug Evaluation and Research (CDER), Office of Clinical Pharmacology, and Office of Translational Science.

“The importance of RWD in the generation of evidence has been accelerating. We see our collaboration with the FDA as generating foundational research and methodologies to advance RWE’s potential uses,” said Jeff Elton, PhD, CEO of ConcertAI. “We look forward to bringing our RWD and data science expertise to this collaboration to help create methodologies for Real-World Evidence (RWE) to accelerate more effective and safe oncology therapeutics.”

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The collaboration builds on the FDA’s program aiming to explore the use of RWD to generate evidence. FDA researchers will utilize ConcertAI’s RWD and eurekaHealth technologies to explore generating RWE and to better understand the outcomes and safety of current treatments within focal subpopulations. The research is also intended to advance technologies that may aid in the management and analyses of RWD.

Specifically, researchers will look to use technologies that can aid in developing RWE to define strategies to improve patient clinical treatment outcomes; optimize the design of clinical trials; and inform approaches to RWD-enabled safety assessments. The collaboration will involve participation of the FDA’s clinical pharmacology, pharmacometrics, genomics, regulatory science and data analysis teams working with ConcertAI’s data science, RWD, AI technologies, and outcomes sciences experts.

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“As a part of the FDA’s Real-World Evidence Program, the agency has multiple work streams and collaborations aiming to inform the potential utility of RWE in therapeutic development and regulatory decision making. Our collaboration with ConcertAI can enable us to explore and evaluate the reliability of new methods, and identify relevant use cases, and ultimately advance the knowledge for all involved stakeholders,” said, Qi Liu, PhD, Senior Science Advisor, Office of Clinical Pharmacology at the FDA.

ConcertAI’s oncology RWD includes millions of patient Electronic Medical Records (EMR) data from a variety of academic and community cancer care settings. These include the CancerLinQ database through ConcertAI’s collaboration with the American Society for Clinical Oncology (ASCO), as well as data from other nationwide community cancer networks.

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