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CancerLinQ partners with FDA, NCI
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CHICAGO — ASCO’s big-data initiative CancerLinQ announced a long-term partnership with the FDA to use patient data to evaluate the real-world use of newly approved cancer therapies, according to a press release.
The initiative also partnered with the NCI to ease data sharing between CancerLinQ-participating cancer centers and the SEER program.
“CancerLinQ is becoming a community that learns together to improve patient care,” Clifford A. Hudis, MD, FACP, FASCO, CEO of ASCO and chairman of the CancerLinQ board of governors, said in the release. “It already includes oncologists, nurses, pharmacists, physician assistants, patient advocates, IT specialists and researchers across the country.”
The FDA–CancerLinQ partnership — which will start by focusing on treatments for advanced melanoma — aims to expand the knowledge base about patterns of care and potentially enhance FDA’s regulatory strategies and decision-making process.
“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,” Sean Khozin, MD, MPH, acting associate director for oncology regulatory science and informatics in the FDA’s Oncology Center of Excellence and director of FDA’s INFORMED initiative, said in the release. “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 partnership will use CancerLinQ Discovery, a research and analytics platform that enables the analysis of real-world, aggregated and de-identified patient data from 90 oncology practices and institutions from 40 states and the District of Columbia.
Although immunotherapies and targeted therapies have changed the melanoma treatment landscape, much is unknown about the benefits and risks of these treatments for the elderly or those with comorbidities because these patients often are ineligible for clinical trials.
Researchers also hope to assess the optimal sequence of treatments, the impact other health problems have on treatment tolerability or cancer outcomes, and the use of immunotherapy combinations vs. monotherapy.
The findings of this partnership stand to inform the development of new clinical trials, drug reviews and labeling refinements.
“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,” Hudis said. “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.”
The goals of the NCI–CancerLinQ partnership are to increase oncologist access to population-level cancer data and expand the nation’s cancer surveillance programs.
In the first phase of this partnership, the two groups will incorporate national SEER data — which includes 18 central cancer registries currently covering approximately 30% of the U.S. population — into CancerLinQ’s data-sharing platform.
The integrated access to SEER data — which includes patient demographics, cancer diagnosis, tumor morphology and stage, first course of treatment, laboratory data and follow-up data — will allow researchers to compare regional- and national-level data with their own practice data.
The second phase will involve development of a system in selected geographic regions for care providers to upload and transmit their own practice data to the SEER program using the CancerLinQ portal. This would make legally mandated cancer surveillance reporting activities more timely, efficient and complete.
“When the cancer community combines its resources, we can greatly increase our chances of improving cancer care,” Lynne Penberthy, MD, MPH, associate director for the NCI surveillance research program, said in the release. “This collaboration will provide cancer data that are difficult to capture from traditional surveillance methods. These additional sources will enhance our ability to understand patient care and outcomes.”