Healthcare Analytics, Population Health Management, Healthcare Big Data

Precision Medicine News

CancerLinQ Partners with FDA for Precision Medicine Studies

Using big data analytics and real-world evidence, CancerLinQ and the FDA will advance precision medicine for cancer care.

Cancer care and precision medicine

Source: Thinkstock

By Jennifer Bresnick

- CancerLinQ and the FDA have entered a long-term partnership centered on studying the real-world impacts of precision medicine therapies for cancer care. 

Using big data analytics and patient data, the two organizations will monitor newly approved cancer therapies to improve the industry’s understanding of patient outcomes.

“This collaboration addresses one of oncology’s central challenges – to quickly learn about the real-world impact of cancer therapies once a drug is approved,” said Clifford A. Hudis, MD, FACP, FASCO, CEO of ASCO and Chairman of the CancerLinQ Board of Governors.

“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. 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, a big data repository and clinical decision support platform for oncologists, has been focusing on expanding its industry collaborations in 2017. 

Earlier this spring, the organization announced a new partnership with the American Academy of PAs, as well as 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 FDA partnership furthers CancerLinQ’s mission of providing oncologists with the large datasets they need to make informed, accurate decisions that incorporate learnings from as many cancer patients as possible.

“This is an important collaboration in our regulatory science research portfolio that can contribute to the development of an empirically-derived framework for incorporation of real-world evidence into regulatory decision making,” said Sean Khozin, MD, MPH, acting associate director for oncology regulatory science and informatics in the FDA’s Oncology Center of Excellence and the director of the FDA’s INFORMED initiative.

“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.”

The collaboration will grow the industry’s knowledge about patterns of care across every type of cancer.  Initially, researchers will focus on treatments for advanced melanoma. 

CancerLinQ and the FDA will chart the real-world experiences of these cancer patients, contribute to the understanding of how to best deliver approved therapies for melanoma, and work to inform future FDA activities surrounding the regulatory review of targeted drugs and immunotherapies.

Results will be shared with the larger cancer community, and may be used to develop future clinical trials.

“We at CancerLinQ are humbled by the opportunity to officially partner with the FDA and, ultimately, share our collective findings with the oncology community,” said Kevin Fitzpatrick, Chief Executive Officer of CancerLinQ LLC.

“We are thrilled to be growing our coalition of collaborators in such a short span of time and be identified as a key resource for the federal agency to support the FDA’s interest and commitment to leverage real-world evidence in their decision making.” 


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