FDA, CancerLinQ Partner for Precision Medicine Studies


The US Food and Drug Administration (FDA) and CancerLinQ—a big data repository and clinical decision support platform in oncology—have entered a partnership for studying real-world impacts of precision medicine therapies for cancer care.


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Utilizing big data analytics and real-world patient data, the partnership will serve as a basis for monitoring newly approved therapies and improving understandings of patient outcomes. Initially, researchers will focus on treatments for advanced melanoma, but future efforts will help increase the industry’s knowledge about patterns of care across every cancer type.

“Until now, our learning about new treatments was hindered by the limited number of physicians and patients involved in traditional research and slowed significantly when formal clinical trials ended,” commented Clifford A Hudis, MD, FACP, FASCO, CEO of ASCO, chairman of the CancerLinQ Board of Governors, in an interview (June 6, 2017). “CancerLinQ Discovery addresses this gap and fulfills the need, picking up where trials leave off and opening up a new world of insights to guide the use of new therapies and improve the lives of everyday patients with cancer.”

CancerLinQ and the FDA will undergo real-world analyses of patients with cancer, contribute to the understanding of how to best deliver approved therapies for melanoma, and inform future FDA activities regarding the regulatory review of targeted drugs and immunotherapies. Resulting data will be made public for the larger cancer community and could help inform future clinical trials.

“Studying the real world experience of patients is an opportunity to not only gain new insights beyond conventional clinical trials, but also advance patient-centered drug development by turning our focus to the point-of-care, where the majority of cancer patients are being treated,” said Sean Khozin, MD, MPH, associate director for oncology regulatory science and informatics, FDA’s Oncology Center of Excellence, in the same interview.

CancerLinQ recently partnered with the American Academy of Physician Assistants, along with previous agreements with the American Society of Radiation Oncology, Cancer Informatics for Cancer Centers, College of American Pathologists, Hematology/Oncology Pharmacy Association, and the Oncology Nursing Society. The partnership with the FDA furthers CancerLinQ’s mission of assisting oncologists with large datasets necessary to make informed, accurate decisions that incorporate learnings from as many patients with cancer as possible.—Zachary Bessette